PD CATHETER
Received Apr 27, 2026
Report MW5187336 · MDR key 25014948
Device
Generic name
Catheter, Peritoneal Dialysis, Single Use
Manufacturer
UnknownPatient
NA · Unknown
- Failure of Implant
- Unspecified Infection
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THIS PERITONEAL DIALYSIS (PD) PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2026 DUE TO AN INFECTION (UNSPECIFIED). THE PD CATHETER (NOT A (B)(6) PRODUCT) WAS REMOVED. THE PATIENT TRANSITIONED TO HEMODIALYSIS (HD). ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) STATED THE PATIENT REMAINED HOSPITALIZED AND THE CLINIC DID NOT HAVE ACCESS TO ANY RECORDS. THE CAUSE OF THE INFECTION WAS UNKNOWN. THE EXACT DIAGNOSIS WAS NOT PROVIDED. IT IS UNKNOWN WHAT TYPE OF INFECTION WAS DIAGNOSED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).