BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1ML BD SAFETYGLIDE¿ TB SYRINGE, 27G X 0.5" BD¿ PERMANENTLY ATTACHED NEEDLE

    MDR report key: 6368622 · Received March 1, 2017

    Report

    Report Number
    1920898-2017-00032
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    February 8, 2017
    Report Date
    February 21, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: RESULT - NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE REPORTED LOT #6131957. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. CONCLUSION - WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE USED THE SUSPECT DEVICE TO ADMINISTER MEDICATION TO PATIENT WITH "SKIN LIFE TECHNIQUE". DURING INJECTION THE PATIENT FLINCHED AND MOVED DURING REMOVAL OF THE DEVICE, WHICH RESULTED IN A NEEDLE STICK INJURY TO THE NURSE'S LEFT HAND. IT WAS NOTED THAT THE PRODUCT FUNCTIONED AS REQUIRED AND THE SAFETY WAS ENGAGED. BLOOD WORK WAS PERFORMED. IT IS UNKNOWN IF THE PATIENT IS POSITIVE FOR AN INFECTIOUS DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153264 1ML BD SAFETYGLIDE¿ TB SYRINGE, 27G X 0.5" BD¿ PERMANENTLY ATTACHED NEEDLE TUBERCULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 6131957

    Patients

    Seq Age Sex Outcome Treatment
    1 Other