MalfunctionEXI
PEDIATRIC URINE COLLECTOR BAG
Received May 11, 2020 · Event occurred Apr 15, 2020
Report 10042468 · MDR key 10042468
Device
Generic name
Device, Paste-on For Incontinence, Sterile
Manufacturer
Precision Dynamics CorporationCatalog number
HP-196-602
Lot number
080208
Product problems
- Tear, Rip or Hole in Device Packaging
- Defective Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
I OPENED THE STERILE PEDIATRIC URINE COLLECTOR BAG WITH LOT # 080208 AND THERE IS A LONG SLIT ALONG THE EDGE OF THE BAG SO IT IS DEFECTIVE AND NOT USABLE. THE BAG WAS USED ON THE PATIENT WHILE IN THEIR HOME FOR URINE COLLECTION, LUCKILY THEY HAD ANOTHER ONE ON HAND OR ELSE THIS WOULD HAVE CAUSED A GREAT DEAL OF DELAY OF CARE SINCE THEY WOULD HAVE TO RETURN TO CLINIC TO PICK UP ANOTHER SUPPLY.