"covering" symbols on blood collection tube

MarRz

Involved In Discussions
Hello,

I just noticed that our packaging department covers medical device symbols on the blood collection tube with our own label. The symbols that are covered are temperature limit, fragile, read IFU and caution. This happens because they need to label the device with an internal barcode before shipping the tube to doctors for use. If they stick our label directly to the glass, it falls off, so they stick it on part of the already existing label.

LOT number, expiry date, CE IVD mark are not covered.

The blood tube is made by other manufacturer. We buy it in bulk and pack each separately in the package (along with other materials) that is later used by the doctor.
Could covering part of the symbols be problematic, and what kind of problems / non-conformance could that be?
 

Billy Milly

Quite Involved in Discussions
Yes. You are changing manufacturer's labelling, hence you are fully responsible for the product.
 

ChrisM

Quite Involved in Discussions
Yes. You are changing manufacturer's labelling, hence you are fully responsible for the product.
^
This..... you need to find a better adhesive for your own labels or else find a transparent tape to apply to the tube (that adheres properly), and to which you then apply your label (also has to adhere properly to the transparent tape). You should not be obscuring existing information
 

MarRz

Involved In Discussions
Thanks. I assumed it is not correct, even if they only cover part of the original label/symbols, but still wanted to check here.
Yeah, the operations will need to change the whole process of labelling and probably invest more in our own labels (to have better adhesive). They won't be happy when I tell them :D
 

dgrainger

Trusted Information Resource
Or.... the OEM has not identified this reasonably foreseeable misuse and needs to take action to lessen the risk of symbols being covered by making a larger sticker with room for an over-sticker. ;)
 
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