FDA Adverse Event Malfunction Summary report: N

POLYURETHANE CONTRAST INJECTION LINE

MDR report key: 1587689 · Received January 20, 2010

Report

Report Number: 1721504-2010-00014
Event Type: Malfunction
Date Received: January 20, 2010
Date of Event: December 9, 2009
Report Date: December 21, 2009
Manufacturer: MERIT MEDICAL SYSTEMS, INC.
Product Code: DXJ
PMA / PMN Number: K883718
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE SUSPECT DEVICES WERE RETURNED FOR EVALUATION. THE DEVICES WERE EXAMINED VISUALLY AND THE COMPLAINT WAS CONFIRMED. THE ROTATORS WERE SEPARATED AT THE BOND BETWEEN THE COLLAR AND THE HOUSING. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. COMPLAINT DATA BASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. THE ROOT CAUSE OF THE MALFUNCTION IS ATTRIBUTED TO FAILURE OF THE ADHESIVE BOND BETWEEN THE ROTATOR HOUSING AND THE ROTATOR COLLAR. CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THIS TYPE OF FAILURE. COMPLAINT DATA WILL BE MONITORED TO VERIFY EFFECTIVENESS OF CORRECTIVE ACTIONS TAKEN. DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED.

Description of Event or Problem · 1

THE ROTATORS OF THE HIGH PRESSURE TUBING ARE COMING APART ON INJECTION. THERE WAS NO HARM OR INJURY TO THE PT. IT WAS REPORTED THAT THREE DEVICES WERE DEFECTIVE. HOWEVER, THE CUSTOMER WOULD NOT PROVIDE INFO FOR EACH OF THE EVENTS REPORTED IN THIS COMPLAINT. THIS SINGLE REPORT IS BEING FILED BECAUSE IT WAS NOT POSSIBLE TO PROVIDE DETAILS OF EACH OF THE THREE EVENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	POLYURETHANE CONTRAST INJECTION LINE	DISPLAY, CATHODE-RAY-TUBE, MEDICAL	DXJ	MERIT MEDICAL SYSTEMS, INC.		F642275

Patients

Seq	Age	Sex	Outcome	Treatment
1				CONTRAST MEDIA