PD CATHETER
Received Aug 12, 2023
Report MW5140555 · MDR key 17533651
Device
Generic name
Catheter, Peritoneal
Manufacturer
UnknownProduct problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT SENT FOR X-RAYS WHICH SHOWED THE PD CATHETER IS "COMPLETELY BENT." THE PATIENT IS HAVING A TUNNEL CATHETER PLACED FOR TEMPORARY HEMODIALYSIS (HD) UNTIL THE PD CATHETER IS REVISED OR REPLACED. UPON FOLLOW UP, THE NURSE CONFIRMED THE PATIENT IS CURRENTLY ON BACK UP HEMODIALYSIS WHILE THE PD CATHETER AWAITS INTERVENTION. THE NURSE CONFIRMED THAT THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS DUE TO ANY FRESENIUS DEVICE, OR PRODUCT. BASED ON THE AVAILABLE INFORMATION, THERE IS NO ALLEGATION OR INDICATION THAT A FRESENIUS DEVICE OR PRODUCT ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS PATIENT HARM OR INJURY. THE CATHETER USED BY THE PATIENT IS NOT A FRESENIUS DEVICE. THE MANUFACTURER OF THE CATHETER, AND FURTHER PRODUCT INFORMATION, IS UNKNOWN. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).