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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 09/04/2020

Event Type  Injury  

Event Description

It was reported that a peritoneal dialysis (pd) patient was hospitalized on (b)(6) 2020 for a pd catheter (not a fresenius product) complication.Additional information was obtained via follow-up with the patient's peritoneal dialysis registered nurse (pdrn).The pdrn reported omentum was found to be wrapped around the patient's pd catheter which caused drain difficulties during pd therapy on the liberty select cycler.The pdrn stated the patient was able to undergo pd therapy on a hospital provided baxter cycler during the admission.The pdrn reported the patient was able to have the omentum surgically moved proximal to the pd catheter and the catheter did not require removal.The pdrn stated the patient had an uneventful hospital course and was discharged on (b)(6) 2020.The pdrn confirmed the patient's pd catheter complication and the associated hospitalization were not due to a deficiency or malfunction of any fresenius product(s), device (s) or drug(s).The pdrn stated the patient has recovered from this event and continues pd therapy on the same liberty select cycler at home.(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: 17530572
• MDR Text Key: 321066424
• Report Number: MW5137491
• 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: 09/18/2020

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