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

Device Problem Unintended Movement (3026)

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

Event Date 12/21/2020

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient's clinic registered nurse (rn) reported the patient was hospitalized for pd catheter malfunction.The nurse states the catheter in all tangled in the patient's peritoneum.It was reported the patient attempted treatment on (b)(6) 2020 but could not complete treatment.The patient went to the outpatient pd clinic later that day and was then placed on back up hemodialysis for dialysis needs.The patient has a scheduled appointment on (b)(6) 2021 to fix the catheter.The catheter is not a fresenius product line.Additionally, there was no allegation against any fresenius products.C-712323, (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: 17525978
• MDR Text Key: 321051593
• Report Number: MW5132919
• 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: 12/23/2020

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