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

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

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Peritonitis (2252)

Event Date 07/26/2020

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was hospitalized (b)(6) 2020 and had their catheter (non-fresenius product) explanted.The patient was reportedly experiencing abdominal pain and was admitted with peritonitis.A pd culture was obtained in the hospital which yielded growth of unspecified fungus (organism not reported: culture not available).Reportedly, the patient was treated in the hospital with unknown medication for the infection.The catheter was explanted on an unknown date and the patient was transitioned to hemodialysis.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERITONEAL CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17526704
• MDR Text Key: 321131078
• Report Number: MW5133642
• 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: 08/17/2020

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