BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIT CUSTOM KIT

    MDR report key: 2043386 · Received February 25, 2011

    Report

    Report Number
    1721504-2011-00074
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    December 21, 2010
    Report Date
    February 3, 2011
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    DTL
    PMA / PMN Number
    K934123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVAL. UPON VISUAL INSPECTION THE COMPLAINT WAS CONFIRMED. THE TOP PORTION OF THE MALE THREADS HAD BROKEN OFF AROUND THE CIRCUMFERENCE OF THE ROTATOR HOUSING. THE ROTATOR COLLAR AND ROTATOR HOUSING BOND REMAINED INTACT. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY EXCEPTION DOCUMENTS. THE COMPLAINT DATABASE WAS REVIEWED AND FOUND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER. A VISUAL INSPECTION OF THE HIGH PRESSURE TUBING LUER BONDED TO THE STOPCOCK SHOWS SIGNIFICANT TOOL MARKS AND DEFORMATION ON THE OUTSIDE SURFACE OF THE LUER. THIS TYPE OF DAMAGE WOULD HAVE ORIGINATED WITH THE CUSTOMER. EVAL METHOD: DEVICE HISTORY RECORD WAS REVIEWED, COMPLAINT DATA BASE WAS REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON THE FOURTH OR FIFTH INJECTION THE THREADED REGION OF THE ROTATOR HOUSING ON THE STOPCOCK BROKE INTO TWO PIECES DURING AN ABDOMINAL ANGIOGRAPHY. INJECTOR SETTING: FLOW 1 ML/SEC. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIT CUSTOM KIT CATHETER, INTRAVASCULAR, DIAGNOSTIC DTL MERIT MEDICAL SYSTEMS, INC. H129900

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO SNIPER2 HIGH FLOW CATHETER| ZONE MASTER ZMODEL INJECTOR| CONTRAST MEDIA