BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE MANUAL NEEDLE GUARD

    MDR report key: 8692224 · Received June 12, 2019

    Report

    Report Number
    3009081593-2019-00150
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    April 30, 2019
    Report Date
    July 3, 2019
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    K972878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PICTURES NOR SAMPLES WERE PROVIDED TO BD MEDICAL -PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS BUT AN ANALYSIS OF THE RETAIN SAMPLE AS WELL AS A BATCH HISTORY RECORD¿S REVIEW (BHR) HAS BEEN PERFORMED. THE RETAIN SAMPLE ANALYSIS AND THE BHR ALLOWED BD TO CONFIRM THE SAFETY DEVICE DIMENSIONAL CONDITION REPORTED BY AMGEN BUT NOT THE BROKEN BARREL ISSUE. THIS DIMENSIONAL CONDITION CAN BE EXPLAINED BY A SUCCESSION OF EVENTS IMPLYING AN IMPROPER INNER DIMENSION TEST METHOD AND AN INAPPROPRIATE EXPANSION OF ITS RE-INSPECTION. NEVERTHELESS, A CORRECTIVE-ACTION WAS ALREADY (UPDATE OF THE WORK INSTRUCTION TT-WI-30020 AND THE RE-TRAINING OF OPERATORS) PUT IN PLACE IN THE FRAMEWORK OF THE DEVIATION WHICH HAS BEEN OPENED BEFORE RELEASING THE BATCH. THIS ACTION SHOULD SHOULD PREVENT AMGEN FROM RECEIVING SAFETY DEVICES WITH OOS INNER DIMENSION. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE OF THE BD ULTRASAFE¿ MANUAL NEEDLE GUARD THERE WAS SYRINGE BREAKAGE RELATED TO BROKEN FLANGE FOUND INSIDE A BLISTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE GENERATED A COMPLAINT (B)(4)FOR SYRINGE BREAKAGE RELATED TO BROKEN FLANGE FOUND INSIDE A BLISTER. ONE OF THE THINGS THAT IT WAS OBSERVED DURING THE FORENSIC ANALYSIS WAS THAT THE UNIT WAS NOT FREELY ROTATING INSIDE THE MNG. WHEN MEASURED THE INNER PORTION OF THE MNG AND COMPARED THAT MEASUREMENT TO ANOTHER MNG (NOT FROM THE SAME BATCH) IT WAS NOTICED THAT THERE WAS A DIFFERENCE IN SIZE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD ULTRASAFE¿ MANUAL NEEDLE GUARD THERE WAS SYRINGE BREAKAGE RELATED TO BROKEN FLANGE FOUND INSIDE A BLISTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE GENERATED A COMPLAINT (B)(4) FOR SYRINGE BREAKAGE RELATED TO BROKEN FLANGE FOUND INSIDE A BLISTER. ONE OF THE THINGS THAT IT WAS OBSERVED DURING THE FORENSIC ANALYSIS WAS THAT THE UNIT WAS NOT FREELY ROTATING INSIDE THE MNG. WHEN MEASURED THE INNER PORTION OF THE MNG AND COMPARED THAT MEASUREMENT TO ANOTHER MNG (NOT FROM THE SAME BATCH) IT WAS NOTICED THAT THERE WAS A DIFFERENCE IN SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485996 BD ULTRASAFE MANUAL NEEDLE GUARD SAFETY SYRINGE WITH NEEDLE MEG BECTON DICKINSON HUNGARY KFT (BD) 6092157

    Patients

    Seq Age Sex Outcome Treatment
    1 Other