BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 8350540 · Received February 19, 2019

    Report

    Report Number
    9616656-2019-00167
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    January 30, 2019
    Report Date
    March 18, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K110007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE OPEN 30G X 5MM AUTOSHIELD DUO PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 8241613, CAT. NO. 329515. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE NON PATIENT END SHIELD WAS INCORRECTLY ASSEMBLED. 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. THE ROOT CAUSE OF THIS ISSUE IS THE ROTATION OF THE NON PATIENT SHIELD LOCKING INTO THE HUB NOT BEING SET CORRECTLY. CAPA 478527 WAS RAISED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE AS THE CUSTOMER WENT TO PUT THE NEEDLE ON TO THE PEN AND BEGAN TO SCREW IT ON, THE PIECES FELL APART.

    Additional Manufacturer Narrative · 1

    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 DURING USE OF THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE AS THE CUSTOMER WENT TO PUT THE NEEDLE ON TO THE PEN AND BEGAN TO SCREW IT ON, THE PIECES FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143260 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8241613 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other