BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22 G X 1 1/2 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 5934686 · Received September 7, 2016

    Report

    Report Number
    1213809-2016-00028
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    August 22, 2016
    Report Date
    August 29, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6021826. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585432 22 G X 1 1/2 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 6021826

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention