BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 2974214 · Received February 11, 2013

    Report

    Report Number
    1024879-2013-00002
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BD
    Product Code
    JKA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS DOCUMENTED FOR THE REPORTED LOT NUMBER. THERE WERE NO ABNORMAL CONDITIONS REPORTED IN THE DHR THAT COULD CAUSE THE DEFECT; NO QUALITY NOTIFICATIONS WERE NOTED. ALL PROCESS AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. NO PRODUCT WAS RETURNED BY THE CUSTOMER FOR EVAL. HOWEVER THIRTY (30) RETAINS WERE EVALUATED. EVAL SUMMARY: THIRTY (30) RETAIN SAMPLES FROM LOT 2222717 WERE EVALUATED FOR HUB THREAD DEFORMATION AND DRAW TESTING. THERE WERE NO OBSERVATIONS MADE FOR ANY OF THESE 30 SAMPLES. UNABLE TO CONFIRM THE REPORTED COMPLAINT AS BEING RELATED TO THE MFG PROCESS. THE DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE CLOSELY MONITORED.

    Description of Event or Problem · 1

    A NURSE WAS USING A LUER ADAPTER WITH HOLDER COMBINATION TO DRAW BLOOD. THE HOLDER SEPARATED FROM THE LUER ADAPTER WHICH REMAINED STUCK IN PORT. WHEN THE NURSE WENT TO REMOVE THE LUER ADAPTER SHE SUSTAINED A NEEDLE STICK INJURY FROM THE NON-PT END OF THE DEVICE. THE PT AND NURSE WERE BOTH TESTED AND THE PT WAS CONFIRMED POSITIVE FOR A COMMUNICABLE DISEASE. THE NURSE WAS TREATED IN THE EMERGENCY DEPT AND STARTED ON MEDICATION IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60527 BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER SAMPLE NEEDLE AND COLLECTION SET JKA BD 2222717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention