BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR PVC CONTRAST INJECTION LINE

    MDR report key: 695733 · Received April 1, 2006

    Report

    Report Number
    1721504-2006-00008
    Event Type
    Malfunction
    Date Received
    April 1, 2006
    Date of Event
    March 2, 2006
    Report Date
    March 2, 2006
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    FPK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN ANGIOGRAM PROCEDURE PERFORMED IN THE RADIOLOGY DEPT. THE ROTATORS ON TWO HIGH PRESSURE TUBING (HPT) STES BROKE. THE SECOND HPT TUBING SET WAS USED TO REPLACE THE FIRST SET, AND THE CONNECTION ALSO BROKE ON THIS SET. THE THIRD SET WAS USED WITHOUT INCIDENT. THE HPT WAS CONNECTED TO A MICRO-CATHETER AND SET FOR A PRESSURE OF 500PSI. CONTRAST AGENT SPRAYED FROM THE BROKEN ROTATORS. HOWEVER, THE SPRAYED CONTRAST AGENT DID NOT CONTACT THE PT OR USERS. NO INJURY OR HARM RESULTED FROM THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEAR PVC CONTRAST INJECTION LINE HIGH PRESSURE TUBING FPK MERIT MEDICAL SYSTEMS, INC. NA F407781

    Patients

    Seq Age Sex Outcome Treatment
    1 *