"D" BAG DRAINAGE SET
Received May 4, 2011 · Event occurred Apr 11, 2011
Report 1036710-2011-00005 · MDR key 2097432
Device
Generic name
Drainage Set
Manufacturer
Angiotech, Medical Device TechnologiesModel number
DBAG600Catalog number
NA
Lot number
030823VI
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THE POUCH IS DRILLED.
Additional Manufacturer Narrative
THE PRODUCT WAS RETURNED FOR REVIEW. THE SEAL OF THE POUCH IS COMPLETE. THERE IS A STRAIGHT CUT MEASURING 3 INCHES ON THE POLY SIDE OF THE POUCH. THIS PRODUCT IS PACKAGED TWENTY TO A BOX. THE TWO FLAPS ON THE END OF THE BOX ARE FOLDED OVER AND TAPED. IF A CUTTING UTENSIL IS USED TO OPEN THE BOX AND IS PUSHED DEEP ENOUGH WHILE CUTTING THE TAPE, THE TOP POUCH MAY BE CUT AS SEEN ON THE RETURNED POUCH. THIS IS THE FIRST REPORT OF THIS OCCURRING. THE DEFECT IS READILY VISIBLE BY THE CUSTOMER. WE WILL CONTINUE TO MONITOR AND TREND TO TAKE ACTION WHEN NECESSARY.