BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NEEDLE 29G ULTRA FINE

    MDR report key: 3031355 · Received March 5, 2013

    Report

    Report Number
    9616656-2013-00008
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. IF A SAMPLE ARRIVES FOR INVESTIGATION A SUPPLEMENTAL WILL BE COMPLETED AND POTENTIAL ROOT CAUSE WILL BE DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT ON AN UNK DATE, THE CALLER REPORTED THAT HER SON DID AN INJECTION AND THE NEEDLE REMAINED IN THE INJECTION SITE. THE PT WENT TO THE EMERGENCY ROOM. THERE WAS AN X-RAY PERFORMED AND THE DOCTOR TRIED TO REMOVE THE NEEDLE BUT COULD NOT. THE PT WAS TOLD TO SOAK THE AREA WITH WARM SOAPY WATER THREE TIMES A DAY AND KEEP AND EYE ON THE SITE FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94781 PEN NEEDLE 29G ULTRA FINE NONE FMI BD 2135196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other