BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6077515 · Received November 3, 2016

    Report

    Report Number
    1213809-2016-00036
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Report Date
    October 17, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE MANUFACTURE DATE: THIS DEVICE WAS MANUFACTURED BETWEEN 9/11/2014 AND 9/19/2014. DEVICE EVALUATION: RESULT - A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4230933. CONCLUSION - AS THERE WAS NO ACTUAL RETURNED SAMPLE FOR EVALUATION, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEEDLE OF THE SUSPECT DEVICE DID NOT RETRACT AFTER INJECTING VITAMIN B12 INTO THE PATIENT'S DELTOID. THE NEEDLE WAS INTACT AND NO HARM CAME TO THE PATIENT OR CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728744 25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 4230933

    Patients

    Seq Age Sex Outcome Treatment
    1 Other