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

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

Patient Problem Peritonitis (2252)

Event Date 06/01/2021

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was diagnosed with peritonitis.The patient was hooked to machine when the symptoms first started.The patient was able to complete treatment but then immediately went to emergency room.Upon follow-up, the patient's primary pd registered nurse {porn) confirmed the patient was hospitalized approximately 30 days ago due to peritonitis.While hospitalized the patient's pd catheter (not a fresenius product) was surgically removed and the patient transitioned to hemodialysis (specifics not provided).Subsequent attempts to obtain additional information (e.G., causality, patient demographics, discharge summary, organism) have thus far proven unsuccessful.The catheter used by the patient is not a fresenius device.The manufacturer of the catheter, and further product information, is unknown.(b)(6), (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: 17525348
• MDR Text Key: 321160229
• Report Number: MW5132289
• 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: 08/02/2021

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