MalfunctionEXF
DRAINAGE BAG
Received Jun 11, 2018 · Event occurred May 2, 2018
Report 7586197 · MDR key 7586197
Device
Generic name
Drainage Bag
Manufacturer
Argon Medical Devices, Inc.Model number
DBAG600Catalog number
DBAG600
Lot number
11208564
Product problems
- Leak/Splash
- Device Inoperable
Patient
Not reported
- No Information
- No Information
Narrative
Description of Event or Problem
DRAINAGE BAG LOT NUMBER 1120856 MALFUNCTIONED. HAD 3 ISOLATED EPISODES OF THE BAGS LEAKING WHEN THE PORT WAS FULLY IN THE CLOSED POSITION. ALL BAGS COLLECTED.