BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER LUER-LOK ACCESS DEVICE

    MDR report key: 1052106 · Received May 2, 2008

    Report

    Report Number
    1052106
    Event Type
    Malfunction
    Date Received
    May 2, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 2, 2008
    Manufacturer
    BD
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE HAD CONNECTED BD VACUTAINER LUER-LOK ACCESS DEVICE TO THE CLAVE CONNECTOR ON A PATIENT'S IV ACCESS DEVICE AND DRAWN BLOOD SPECIMENS. WHEN SHE TRIED TO REMOVE THE LUER-LOK ACCESS DEVICE FROM THE CLAVE THE TIP OF THE DEVICE BROKE OFF AND REMAINED LODGED IN THE CLAVE CONNECTOR. THE ACCESS DEVICE UNSCREWED FROM THE CLAVE BUT THE TIP REMAINED BEHIND. NURSE REPLACED THE CLAVE CONNECTOR WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VACUTAINER LUER-LOK ACCESS DEVICE TUBE, EVACUATED, SPECIMEN COLLECTION JKA BD 364902 8028118
    2 * CLAVE CONNECTOR FPA HOSPIRA GLOBAL MEDICAL AFFAIRS MODEL # 11956 LOT # 59-44-SN

    Patients

    Seq Age Sex Outcome Treatment
    1 *