BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ORIGINAL PEN NEEDLE

    MDR report key: 2922140 · Received January 11, 2013

    Report

    Report Number
    9616656-2013-00002
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 25, 2012
    Report Date
    January 11, 2013
    Manufacturer
    BD
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE. UNABLE TO RUN COMPLAINT HISTORY CHECK OR DEVICE HISTORY REVIEW AS LOT NUMBER IS UNKNOWN. QUALITY WILL CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    CUSTOMER EXPERIENCED A NEEDLE BREAK OFF IN HIS ABDOMEN. HE WENT TO THE EMERGENCY ROOM WHERE HE HAD AN X-RAY. NEEDLE WAS FOUND ON X-RAY. THE DOCTOR APPLIED LOCAL ANESTHETIC AND MADE AN INCISION TO RETRIEVE NEEDLE. THE NEEDLE WAS NOT FOUND. A SECOND X-RAY DID NOT SHOW THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16637 BD ORIGINAL PEN NEEDLE 12.7MM X 29G PEN NEEDLE FMI BD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention