MalfunctionEXF
DRAINAGE BAG
Received Jan 31, 2018 · Event occurred Dec 28, 2017
Report 7230174 · MDR key 7230174
Device
Generic name
Bag, Bile Collecting
Manufacturer
Argon Medical Devices, Inc.Model number
DBAG600HCatalog number
DBAG600H
Lot number
11112308 AND 11110997
Product problems
- Leak/Splash
- Defective Device
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
RECEIVED NOTE FROM NURSING FLOOR, ISSUES WITH THE ARGON DRAINAGE BAG, REF DBAG600, LOT 11110997, 600 ML, SEALS AT BOTH ENDS OF THE BAG ARE LEAKING, PRODUCT IS DEFECTIVE.