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

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Received follow up information from the pdrn stating that patient had the catheter repositioned.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: 17536594
• MDR Text Key: 321377147
• Report Number: MW5143479
• 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: 04/20/2018

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