BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DANTEC

    MDR report key: 5649705 · Received May 12, 2016

    Report

    Report Number
    3004827015-2016-00004
    Event Type
    Injury
    Date Received
    May 12, 2016
    Date of Event
    April 19, 2016
    Report Date
    May 12, 2016
    Manufacturer
    ALPINE BIOMED APS
    Product Code
    IKT
    PMA / PMN Number
    K931966
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD FOR LOT NUMBER 60530 WAS OBTAINED AND REVIEWED. ALL IN-PROCESS TESTING GAVE ACCEPTABLE RESULTS. SAMPLE WAS CARRIED OUT AND APPROVED ACCORDING TO SP MEDICAL CONTROL SPECIFICATIONS AND QUALITY REVIEW. NO NCRS NOTED FOR THIS LOT. NO REWORKS CARRIED OUT ON THIS LOT. NO CAPAS LINKED TO THIS LOT. COMPLAINTS LOG REVIEWED FOR SIMILAR COMPLAINTS SINCE 2014, NO SIMILAR COMPLAINTS RECEIVED ON THESE DANTEC NEEDLES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DOCTOR HAD STUCK HIMSELF WITH A USED NEEDLE. AFTER USING THE NEEDLE ON THE PATIENT THE DOCTOR WAS TRYING TO COVER THE NEEDLE POINT AND THE NEEDLE POKED THROUGH THE SHEATH AS IT WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306085 DANTEC DISPOSABLE CONCENTRIC NEEDLE IKT ALPINE BIOMED APS 101468 60530

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention