FDA.reportPublic FDA data

MAUDE MDR 8105550

MDR report key
8105550
Report number
8105550
Event key
0
Event type
3
Date of event
2018-10-17
Date received
2018-11-27
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DRAINAGE BAGBAG, BILE COLLECTINGARGON MEDICAL DEVICES, INC.EXFDBAG600DBAG60011227517* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-270

Event Narratives#

D

Patient 1

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.