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

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

Patient (s.R.) reported liquid spewing from the catheter.Follow up confirmed that there was a hold in the pd catheter and fluid leaked.The peritoneal dialysis registered nurse (pdrn) stated that a culture was taken and confirmed that the patient developed peritonitis.The patient was treated with vancomycin and gentamicin.The patient was recovering and continued pd therapy.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17527708
• MDR Text Key: 321081411
• Report Number: MW5134640
• 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: 05/22/2018

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