BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 8103053 · Received November 26, 2018

    Report

    Report Number
    2243072-2018-01717
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 6, 2018
    Report Date
    March 11, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K110007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    NEW INFORMATION RECEIVED CONFIRMED THE CATALOG AND LOT NUMBERS. IT WAS REPORTED THAT THE SAFETY MECHANISM OF THE BD AUTOSHIELD DUO SAFETY PEN NEEDLE DID NOT ACTIVATE AND RESULTED IN A NEEDLE STICK TO THE NURSE. IT WAS ALSO REPORTED THAT "SHE WENT TO EMPLOYEE HEALTH" FOR MEDICAL INTERVENTION. MEDICAL DEVICE BRAND NAME: BD AUTOSHIELD DUO SAFETY PEN NEEDLE. MEDICAL DEVICE CATALOG #: 329515. MEDICAL DEVICE LOT #: 8115755. MEDICAL DEVICE MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: 2021-05-31. (B)(4). PMA/510(K)#: K110007. DEVICE MANUFACTURE DATE: 2018-04-25.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY MECHANISM OF THE BD AUTOSHIELD DUO SAFETY PEN NEEDLE DID NOT ACTIVATE AND RESULTED IN A NEEDLE STICK TO THE NURSE. IT WAS ALSO REPORTED THAT "SHE WENT TO EMPLOYEE HEALTH" FOR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY MECHANISM OF THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE DID NOT ACTIVATE AND RESULTED IN A NEEDLE STICK TO THE NURSE. IT WAS ALSO REPORTED THAT "SHE WENT TO EMPLOYEE HEALTH" FOR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM OF THE UNSPECIFIED BD AUTOSHIELD DUO¿ PEN NEEDLE DID NOT ACTIVATE AND RESULTED IN A NEEDLE STICK TO THE NURSE. IT WAS ALSO REPORTED THAT "SHE WENT TO EMPLOYEE HEALTH" FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941824 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8115755

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention