BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD¿ DUO PEN NEEDLE 30GX5MM

    MDR report key: 5905223 · Received August 25, 2016

    Report

    Report Number
    9616656-2016-00053
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    August 23, 2016
    Report Date
    September 15, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K110703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A LOT # WAS PROVIDED WITH THE RETURNED SAMPLES. THE INFORMATION FOR THE LOT # IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6033791. MEDICAL DEVICE EXPIRATION DATE: 1/31/2019. MEDICAL DEVICE MANUFACTURE DATE: 2/2/2016. DEVICE EVALUATION: RESULTS: SIX SEALED SAMPLES WERE RETURNED FOR EVALUATION. ALL RETURNED SAMPLES WERE TESTED AND ALL WERE ABLE TO ACTIVATE PROPERLY. THE INNER, OUTER, AND NP SHIELDS ALL ACTIVATED PROPERLY ON ALL RETURNED SAMPLES. ALSO, THE RED BAND WAS VISIBLE ON ALL SAMPLES AFTER ACTIVATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6033791. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE OBTAINED A CONTAMINATED NEEDLE STICK INJURY FROM A BD AUTOSHIELD⠄UO PEN NEEDLE 30GX5MM DUE TO THE SAFETY NEEDLE NOT RETRACTING AFTER USE. BOTH THE NURSE AND THE SOURCE PATIENT RECEIVED POST EXPOSURE LAB WORK. THE RESULTS OF THE TEST WERE NEGATIVE AND NO FURTHER FOLLOW UP WAS REQUIRED. ADDITIONALLY, THE NURSE RECEIVED A TETANUS VACCINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555964 BD AUTOSHIELD¿ DUO PEN NEEDLE 30GX5MM SAFETY INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6033791

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention