BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3 ML BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE 25 G X 5/8 IN

    MDR report key: 6904328 · Received September 29, 2017

    Report

    Report Number
    1920898-2017-00247
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    August 17, 2017
    Report Date
    September 8, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7020672. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO NOTIFICATIONS NOTED DURING THE PRODUCTION OF THE ABOVE LISTED BATCHES. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE USING THE 3 ML BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE 25 G X 5/8 IN TRIED TO ENGAGE THE SAFETY USING TWO HANDS. HER INDEX FINGER SLIPPED OFF THE GUARD AND PUNCTURED HER RIGHT PROXIMAL INDEX FINGER THROUGH HER GLOVED HAND. NURSE RECEIVED POST EXPOSURE LAB WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684235 3 ML BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE 25 G X 5/8 IN SAFETY ENGINEERED SYRINGE AND NEEDLE FMI BD MEDICAL - DIABETES CARE 7020672

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention