BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER ECLIPSE NEEDLE

    MDR report key: 2903636 · Received January 4, 2013

    Report

    Report Number
    1024879-2013-00001
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 29, 2012
    Report Date
    January 4, 2013
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. THERE WERE NO ABNORMAL CONDITIONS REPORTED IN THE DHR THAT COULD CAUSE THE DEFECT, AS WELL AS NO QUALITY NOTIFICATIONS WERE NOTED. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED.

    Description of Event or Problem · 1

    NURSE WAS PREFORMING A ROUTINE BLOOD TEST. UPON ACTIVATING THE SHIELD, THE SHIELD BROKE AND NURSE SUSTAINED A NEEDLE STICK INJURY. THE NURSE HAD BLOOD WORK DONE AND RECEIVED (B)(6) BOOSTER SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3950 BD VACUTAINER ECLIPSE NEEDLE 21G ECLIPSE NEEDLE FMI BD 2061465

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention