MalfunctionEYZ
KENDALL
Received Jul 23, 2008 · Event occurred Jul 20, 2008
Report MW5007783 · MDR key 1081410
Device
Generic name
Drainage Bag
Manufacturer
Tyco Healthcare GroupModel number
MONO FLOCatalog number
6208
Lot number
814050864
Product problems
- Restricted Flow rate
- Kinked
- Replace
Patient
54 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
PT'S CAREGIVER CHANGED THE FOLEY CATHETER DRAINAGE BAG AND THE TUBING FOR URINE TO DRAIN INTO THE BAG WAS NOTED TO BE PERMANENTLY KINKED WHERE THE URINE WOULD DRAIN INTO THE COLLECTION BAG. THE CAREGIVER SAVED THE INFO FOR ME TO REPORT AS I AM THE PT'S WEEKLY VISITING HOME CARE NURSE. FORTUNATELY, THE PT HAD AN EXTRA COLLECTION BAG, AS THE DME SUPPLY CO HAS BEEN RATIONING HER SUPPLIES. THE PT IS A QUADRIPLEGIC AND REQUIRES AN ONGOING FOLEY CATHETER FOR URINARY ELIMINATION.