Silhouette Tubing Failure

This morning I woke up to find my pump was disconnected. The tubing had broken during the night. My BG was 19.2 mmol/L or 345 mg/dl. I felt terrible and I haven’t been able to work today. I use Silhouette cannulas (30 degree insertion angle).

I move around in my sleep, which pulls on the tubing. Then the tubing detaches from the plastic collar at the point circled in red. There is not a lot of glue holding the tubing in place. Looking at the broken set, it’s hardly surprising that it broke.

This has happened 4 times. The last 3 times it occurred during the night, so I woke up dangerously high.

I wanted to warn others and to ask if any have had the same experience. Each time I phone up Medtronic to report the problem. They say that they’ll send out a returns cannister, but I have never received one. I wonder if the problem will ever be investigated properly.

Somehow I find it not so bad if the whole cannula becomes unstuck due to strain on the tubing. It can’t be helped. The tubing popping out of the collar is more serious (in my opinion). I used the 90 degree Quickset cannulas for many years and never had this infusion set break.

I have been putting the pump inside my night-clothes to stop the tubing from being pulled. Last night I forgot and paid the price.

Have you reported this to the FDA as a medical device failure? Dont count on your pump co to do this.

Search for FDA Adverse Event Reporting System

Also heard of the needles in the contact Detach sets breaking off and remaining under skin when sets are removed. Not fun either.

Thanks for the advice. I will fill out the form on the FDA's website now.

Wow! That isn’t good! Surprised Medtronic is seemingly slow on the uptake of investigating this. You probably should talk to a supervisor. I am going to ask my Medtronic trainer when I see them! Maybe they can get someone ‘interested’ in the problem. Have you tried taping the tubing to you about maybe an inch or so from the infusion set? Maybe this might help prevent any pulling/kinking that can cause it to break.

Best of luck!


Yeap, agree with 2hobbit1. Definitely report the issue!


Reported the adverse event.

It's disappointing, I used to think highly of Medtronic. I like the pump itself. I have just talked to them on the phone and have been assured that the returns canister will be sent out this evening. I hadn't thought of tape, but I think it will help to take some of the strain. I will get some surgical (Micropore) tape and give it a try. Thank you.

I will ask to talk to a supervisor if the returns canister does not appear by the end of the week.

Malcolm - You’ve raised a legitimate complaint that deserves attention from the FDA and Medtronic. Medtronic’s lack of response to your earlier calls is an issue in itself.

We depend on these devices and supplies as if our life depends on it, because it does! We pay top dollar and have a right to expect high quality and responsive customer service.

I’m glad to read hobbit’s advice to report the adverse event to the FDA as well as your immediate follow up with the FDA. This is exactly how we keep these various medical suppliers honest. Please post any follow up news about this.

When I first started pumping insulin I used to curl a small loop of tubing a few inches away from the site and then tape down that loop. The idea was to create strain relief for the actual site. I stopped doing it since it was an extra step and required extra supplies. Until this situation resolves, perhaps you might consider that practice. Good luck.

Wow, I use these and would not have thought it possible without the picture.

I am going to be changing infusion sets from Silhouette back to the Quickset after what has happened. Nevertheless I want to make sure that this issue gets attention from Medtronic and the FDA, because it is dangerous. I agree that the way it has been handled so far is worrying. Updates will be posted here. I like the idea of the creating the strain relief with tape. Creating the loop also makes the tubing shorter, which is how I'd prefer it. Thanks.

I have used Silhouette cannulas for about 2 years without a problem. The 4 tubing breakages have all occurred within the past 2 or 3 months.

Medtronic have told me this evening that they are conducting a full investigation. An apology has been made about the returns canister.

I have had had several just like your photo and have sent them back to Medtronic. They said someone from Engineering would call me to investigate it's been over a year I'm still waiting. I have also had this happen with Quick-sets. I do know from experience that if you get skin prep on the glue at the connection point it will let go....looking just like your photo...(I'm not saying this is what happened in your case).I don't think your pulling the
tubing out, I have hug and tugged many infusion sits out and the tubing never failed from pulling on has always been a mystery when it happens.

The last time it happened to me I was in DK, BG was > took me several days to recover and lost time from work.

Have you reported any of your failures to the FDA adverse event reporting system.

The more people that do the more likely it is that improvements will be made.
A 600 BG due to a failure is not an acceptable out come. If it is the skin prep that is causing the failure then the manufacturer needs to change/fix their glue issue. This kind of info reported to the FDA will expedite action on this issue. If it is the cause of only a few of these failures then there is a whole different issue going on. Either way it needs to be addressed, and the FDA can help make it happen.

I use the Silhouette and I have had a few break at that same spot. I do think that I was being very rough with the site. As for Medtronic I have never had an issue that did not seem to get fixed quickly. I am glad that they have replaced the Silhouette.

You might want to post your complaint on Medtronics Facebook page. They surely don't want negative comments from their customers. I've posted on their FB page when I had a problem that went ignored by their customer service people. It seems that posting on FB gets results.

I'm sorry to read that this happened to you. I thought that others could be affected by the tube breaking and that it could lead to DKA. It's really bad that Medtronic did not complete the investigation when you have reported it to them several times before. It's similar to what happened to me, the company gave me some assurances and forgot about it. I agree with 2hobbit1, if the FDA get involved I doubt that Medtronic will be allowed to forget. I haven't used skin prep, but it's interesting that it weakens the glue.

For me too, the tubing has been tugged many times when I've been awake (usually after getting caught on door handles). Only once can I remember it becoming unstuck.

During my sleep the tubing can wrap around my body before it reaches the cannula. As a result, the tubing gets pulled at an angle and for a longer period of time. The connection might be stronger if the tubing is pulled straight than it is when the tubing is pulled at angle. There is no strain relief at the connection point.

Actually I have been wearing a pump for several years and I had my very first tubing failure two weeks ago. Just like yours mine broke at the connection to the site. Also like yours mine snapped in the night. I never saw this before. The difference is that it occurred on a quik set. I did contact Medtroinc and let them know, I declined a replacement (I had extra's) but what the heck was that all about? Now I see your post. Crazy tunes huh!