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

Device Problem Material Puncture/Hole (1504)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Peritoneal dialysis patient's malfunctioning catheter (manufacturer and device name is unknown) was repaired for a hole which resulted in the patient being infected and treated for gram positive cocci in clusters.Patient was cultured on (b)(6)2018.The patient was treated with vancomycin.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: 17534316
• MDR Text Key: 321160940
• Report Number: MW5141219
• 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: 05/31/2018

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