MalfunctionEXF
DRAINAGE BAG
Received Nov 27, 2018 · Event occurred Oct 17, 2018
Report 8105550 · MDR key 8105550
Device
Generic name
Bag, Bile Collecting
Manufacturer
Argon Medical Devices, Inc.Model number
DBAG600Catalog number
DBAG600
Lot number
11227517
Product problems
- Leak/Splash
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ARGON DRAINAGE BAGS LOT # 11227515 LEAKING FROM BLUE NOZZLE WHEN ATTACHED TO PATIENT. OUR NURSE WENT THROUGH FOUR FROM THIS SAME LOT NUMBER AND NONE OF THE NOZZLES CLOSE PROPERLY. SHE FINALLY FOUND SOME WITH A DIFFERENT LOT NUMBER THAT WORKED. MANUFACTURER RESPONSE FOR DRAINAGE BAG, ARGON MEDICAL DEVICES (PER SITE REPORTER). LEFT MESSAGE. NO RESPONSE.