BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD

    MDR report key: 14655352 · Received June 10, 2022

    Report

    Report Number
    3009081593-2022-00002
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 16, 2022
    Manufacturer
    BECTON DICKINSON HUNGARY KFT (BD)
    Product Code
    MEG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0024796. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024. DEVICE MANUFACTURE DATE: 24-JAN-2020. MEDICAL DEVICE LOT #: 0034002. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2025. DEVICE MANUFACTURE DATE: 03-FEB-2020. MEDICAL DEVICE LOT #: 0013216. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024. DEVICE MANUFACTURE DATE: 13-JAN-2020. MEDICAL DEVICE LOT #: 0135950. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2024. DEVICE MANUFACTURE DATE: 13-JAN-2020. MEDICAL DEVICE LOT #: 1011472. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2025. DEVICE MANUFACTURE DATE: 11-JAN-2021. MEDICAL DEVICE LOT #: 1087058. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026. DEVICE MANUFACTURE DATE: 28-MAR-2021. INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR DETACHED SYRINGE DEVICE DETECTED BY END USER. PHOTOS WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON INVESTIGATION CONCLUSION A SYRINGE CAN ONLY BECOME DETACHED IF SYRINGE CAPTURE FEATURES OR THE FLANGE OF THE SYRINGE GET DAMAGED/BROKEN OR IF THE SYRINGE RECEIVES AN IMPACT AFTER SYRINGE INSERTION WHICH CAUSES IT TO UNCLIP FROM THE DEVICE. THEREFORE, THE SYRINGE MOST LIKELY BECAME DETACHED AS IT WAS NOT CLIPPED INTO THE DEVICE PROPERLY OR IT RECEIVED AN EXTERNAL IMPACT AFTER SYRINGE INSERTION WHICH CAUSED IT TO UNCLIP FROM THE DEVICE. NONE OF THESE CAUSES ARE RELATED TO BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD EXPERIENCED SAFETY DEVICE SEPARATION BEFORE USE. THIS OCCURRED 3 TIMES IN LOT 0024796, 4 TIMES IN LOT 0034002, ONCE IN LOT 0013216, 6 TIMES IN LOT 0135950, 3 TIMES IN LOT 1011472, AND ONCE IN LOT 1087058. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SAFETY DEVICE FOUND SEPARATED FROM SYRINGE BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678525 BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD ANTISTICK SYRINGE MEG BECTON DICKINSON HUNGARY KFT (BD) SEE SECTION H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown