BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE 30GX5MM

    MDR report key: 5880275 · Received August 16, 2016

    Report

    Report Number
    9616656-2016-00052
    Event Type
    Injury
    Date Received
    August 16, 2016
    Date of Event
    July 26, 2016
    Report Date
    September 9, 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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: BD RECEIVED 1 ACTUAL SAMPLE AND 1 REFERENCE SAMPLE FROM THE REPORTED LOT NUMBER. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - BD RECEIVED ONE OPEN SAMPLE, ONE SEALED SAMPLE AND 6 PHOTOS FROM THE REPORTED CATALOG 329705, LOT 5210805. A VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND NO ISSUES WERE FOUND. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON-CONFORMANCES WAS RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CONCLUSION - BD WAS NOT ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE AS NO ISSUES WERE FOUND ON THE RETURNED SAMPLES AND PHOTOS. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECOND YEAR NURSE WAS GIVING AN INSULIN INJECTION TO A PATIENT USING THE SUSPECT DEVICE FOR THE FIRST TIME. THE NURSE TOUCHED THE TIP OF THE DEVICE TO DETERMINE WHETHER OR NOT THE SAFETY MECHANISM HAD ACTIVATED. SHE SUSTAINED A NEEDLE STICK INJURY TO HER FINGER AS THE SAFETY MECHANISM ACTIVATED AT THE SAME TIME. IT IS UNKNOWN IF THERE WERE ANY MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531730 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE 30GX5MM INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 5210805

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other