InjuryEXF
DAVOL
Received Aug 25, 1997 · Event occurred Aug 6, 1997
Report MW1012005 · MDR key 117140
Device
Generic name
Bile Bag
Manufacturer
Bard/davol Inc.Model number
0015850Catalog number
0015850
Lot number
76EG2838
Product problems
- False Device Output
- Nonstandard Device
- Product Quality Problem
- Valve(s), failure of
Patient
*
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
"URINE" BAG DID NOT DRAIN PROPERLY. THE BAG HAS A FLUTTER VALUE ATTACHED TO THE WRONG END OF THE BAG. BILE BAG WAS IMPROPERLY MFG. THIS IS THE THIRD FAILURE OF THIS TYPE IN THE PAST 9 MONTHS.