FDA Adverse Event Injury Summary report: N

FLEX-NECK PERITONEAL DIALYSIS CATHETER

MDR report key: 2912844 · Received January 9, 2013

Report

Report Number: 1721504-2013-00008
Event Type: Injury
Date Received: January 9, 2013
Date of Event: December 1, 2012
Report Date: December 10, 2012
Manufacturer: MERIT MEDICAL SYSTEMS, INC.
Product Code: FJS
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE USER DID NOT SPECIFY IF THIS WAS THE INITIAL USE OF THE DEVICE. THE CATALOG NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE ACTUAL DATE OF EVENT WAS NOT PROVIDED AND IS AN ESTIMATE. THE IMPLANT AND EXPLANT DATES WERE NOT PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION HAS BEEN COMPLETED.

Description of Event or Problem · 1

THE HOSPITAL REPORTED THE SUBCUTANEOUS CUFF OF THE CATHETER HAD BECOME EXPOSED. IT IS NOT KNOW IF THIS WAS DUE TO THE PATIENT OR NOT. THE PATIENT HAS AUTISM AND PULLS ON THE DIALYSIS CATHETER. THIS WAS THE THIRD CATHETER PLACED DUE TO THE PATIENT PULLING THE PREVIOUS TWO OUT WITHIN A FEW WEEKS. THIS CATHETER WAS IMPLANTED APPROXIMATELY ONE YEAR EARLIER. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, THE PERITONEAL CUFF REMAINED IN THE PATIENT. DUE TO PATIENT HISTORY OF CHRONIC INFECTIONS, THE CUFF WAS REMOVED FROM THE PATIENT. THERE WAS AN INFECTION IDENTIFIED AT TIME OF CUFF REMOVAL. DUE TO THE INFECTION, THE PATIENT DID NOT RECEIVE A REPLACEMENT CATHETER AND WAS DIALYZED BY OTHER MEANS. NO ADDITIONAL HARM OR INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
11661	FLEX-NECK PERITONEAL DIALYSIS CATHETER	CATHETER, PERITONEAL, LONG-TERM	FJS	MERIT MEDICAL SYSTEMS, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention