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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Peritonitis (2252)

Event Date 02/21/2021

Event Type  Injury  

Event Description

A peritoneal dialysis (pd) patient had abdominal pain and was hospitalized on (b)(6) 2021 for the peritonitis infection.During hospitalization, the pd catheter was removed, and the patient was transitioned to hemodialysis.The patient also received unknown antibiotic therapy.The patient was discharged on (b)(6) 2021 continuing outpatient hemodialyis.The patient is reportedly recovering.The nurse states the patient did not have any fluid leaks or any issues with fresenius device, product or drug.The nurse attributed the peritonitis to touch contamination during the pd exchange.(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: 17535532
• MDR Text Key: 321153393
• Report Number: MW5142429
• 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: 04/19/2021

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