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

Catalog Number 0607550

Device Problems Crack (1135); Defective Component (2292)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

This is a report by a nurse in the usa of peritonitis in a male patient.On an unknown date in (b)(6) 2011 the patient was hospitalized and diagnosed with peritonitis.Treatment rendered for the events was not reported.On an unknown date in (b)(6) 2011, the patient was discharged from the hospital.The nurse believes that the peritonitis was caused from a catheter crack.The patient recovered from the peritonitis.On (b)(6) 2012, product surveillance spoke with the nurse regarding the cracked catheter.The nurse believes that the peritonitis was caused by the cracked catheter.The nurse stated that she did not know the manufacturer of the catheter.The nurse stated that the event of peritonitis was unrelated to the peritoneal dialysis therapy.The nurse further indicated that the patient is doing well and is on hemodialysis.Patient injury reported: yes medical intervention required: unknown (b)(4).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: 17524350
• MDR Text Key: 321131954
• Report Number: MW5131297
• 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: 05/03/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 0607550
• Patient Sequence Number: 1