BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.5 MICROEZ UNIVERSAL PTFE MICROINTRO SAFETY KIT

    MDR report key: 3980212 · Received July 2, 2014

    Report

    Report Number
    3006260740-2014-00337
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 9, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    DYB
    PMA / PMN Number
    K915167
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. THIS COMPLAINT IS CONFIRMED AND WILL BE RECORDED AS USER RELATED. EVIDENCED BY THE SAMPLE RETURNED THE GUIDEWIRE HAS BEEN DAMAGED THROUGH USE. THE USER SHOULD NOT PULL BACK THE GUIDEWIRE OVER THE NEEDLE BEVEL AS THIS MAY DAMAGE THE GUIDEWIRE. THE DAMAGE INCURRED TO THE GUIDEWIRE EXHIBITS TENSILE ELONGATION OF THE OUTER COILS. THE INTRODUCER SHEATH/DILATOR AND INTRODUCER NEEDLE WERE NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    A 4FR MICROINTRODUCER. BURR WAS FOUND AT END OF GUIDEWIRE, WIRE GOT STUCK IN MICROINTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388827 4.5 MICROEZ UNIVERSAL PTFE MICROINTRO SAFETY KIT DYB BARD ACCESS SYSTEMS INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention