MAUDE Adverse Event Report: UNKNOWN PERITONEAL DIALYSIS CATHETER; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Device Problems Appropriate Term/Code Not Available (3191); Material Split, Cut or Torn (4008)

Patient Problems Bacterial Infection (1735); Peritonitis (2252)

Event Type  Injury  

Event Description

Baxter contacted the peritoneal dialysis nurse (pdrn) on 17jun2011 regarding a report of hospitalization.The nurse stated that she was aware of the hospitalization and stated that the hp also experienced bacterial peritonitis- culture positive for klebsiella, while hospitalized.She added that the hp had fluid overload and a tear was discovered in his peritoneal dialysis (pd) catheter in (b)(6) 2011.Treatment included pd catheter removal and a change to hemodialysis.The hp at the time of this report was still hospitalized with the events unresolved.The cg believed the events were due to the hp's inability to perform pd therapy properly.The nurse did not provide an opinion of causality.Patient injury reported: yes medical intervention required: yes (b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17532600
• MDR Text Key: 321142506
• Report Number: MW5139507
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1