BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET - FMK

    MDR report key: 2677266 · Received July 27, 2012

    Report

    Report Number
    9613304-2012-00007
    Event Type
    Malfunction
    Date Received
    July 27, 2012
    Date of Event
    July 12, 2012
    Report Date
    July 27, 2012
    Manufacturer
    HTL STREFA S.A.
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    HTL RECEIVED ONE PIECE OF DEFECTED LANCET WITH NO RETRACED NEEDLE - DETECTED DEFECT IS TOO LONG NEEDLE EXPOSURE. HTL TESTED THE RETAINED SAMPLE OF LANCETS FROM LOT NUMBER R25C44L7. THESE TESTS DID NOT CONFIRM THE FAILURE.

    Description of Event or Problem · 1

    NEEDLE OF SAFETY LANCET DID NOT COME BACK AFTER USING IT, AND A NURSE GOT A NEEDLE STICK ACCIDENT. THE NURSE DOES NOT PLAN TO GET ANY EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANCET - FMK FMK HTL STREFA S.A. 590 R25C44L7

    Patients

    Seq Age Sex Outcome Treatment
    1