BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA 3ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 3854907 · Received May 28, 2014

    Report

    Report Number
    2243072-2014-00114
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BD
    Product Code
    FMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING THE INCIDENT HAS BEEN REQUESTED. A PREPAID MAILING LABEL AND SHIPPING TUBE HAVE BEEN SENT FOR RETURN OF THE SAMPLE. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED, (B)(4).

    Description of Event or Problem · 1

    THE NEEDLE DETACHED IN THE INJECTION SITE. AN ULTRASOUND WAS PERFORMED IN THE EMERGENCY ROOM, WHICH CONFIRMED THE NEEDLE WAS IN THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314986 BD INTEGRA 3ML SYRINGE WITH DETACHABLE NEEDLE 3ML SYRING WITH NEEDLE FMF BD 9272982

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention