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

Device Problems Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A patient with end stage renal disease (esrd) on continuous cyclic peritoneal dialysis (cc(pd)] for renal replacement therapy (rrt) was hospitalized.Follow-up with the patient's pd registered nurse (porn) confirmed the patient was hospitalized on (b)(6) 2021 due to drain complications during pd therapy.Radiological testing revealed the patient's pd catheter (not a fresenius product) had migrated out of position and would require surgical intervention.On (b)(6) 2021, the patient successfully underwent the surgical repositioning of his pd catheter and underwent ccpd later the same evening without issue.The patient was discharged on (b)(6) 2021 and has recovered from 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: 17526797
• MDR Text Key: 321408913
• Report Number: MW5133734
• 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: 06/03/2021

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1