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

Catalog Number UNKNOWN PD CATHETER

Device Problem Malposition of Device (2616)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2021

Event Type  Injury  

Event Description

On 17/aug/2021, fresenius became aware this 72-year-old female patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis [cc(pd)) for renal replacement therapy (rrt) was hospitalized and underwent a pd catheter (not a fresenius product) change (specifics not provided).No additional information provided during discovery.Follow-up with the patient's peritoneal dialysis registered nurse (porn) confirmed the patient was hospitalized on (b)(6) 2021 for a mal-positioned pd catheter.On (b)(6) 2021, the patient successfully underwent a pd catheter revision and was discharged several hours later in stable condition.The patient's pd therapy was held while the patient was hospitalized.However following discharge, the patient resumed undergoing ccpd therapy without issue and is recovering from the events.The porn stated the events were unrelated to any fresenius device(s) and/or product(s) defect or malfunction.Upon discharge, the patient resumed utilizing the same liberty select cycler as before the events.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PD CATHETER
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17532247
• MDR Text Key: 321104525
• Report Number: MW5139155
• 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: 08/27/2021

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
• Device Catalogue Number: UNKNOWN PD CATHETER
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1