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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

Patient (d.O.B.(b)(6) 1959) reported being hospitalized on (b)(6) 2016 due to peritonitis.Patient reported ceasing peritoneal dialysis treatments due to the catheter being removed.Patient stated that peritonitis was caused by aseptic technique.Patient was treated with empiric antibiotics.Patient was discharged from the hospital on (b)(6) 2016.Upon review of the patient's medical records, it was indicated that the patient's catheter (tunnel infection) was the cause of the peritonitis.Patent will resume treatment at an in center dialysis clinic.N/a this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17537220
• MDR Text Key: 321150725
• Report Number: MW5144100
• 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: 04/21/2016

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
• Patient Sequence Number: 1