BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15487333 · Received September 26, 2022

    Report

    Report Number
    1213809-2022-00640
    Event Type
    Malfunction
    Date Received
    September 26, 2022
    Date of Event
    September 2, 2022
    Report Date
    September 30, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2003405, MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, DEVICE MANUFACTURE DATE: 03-JAN-2022. MEDICAL DEVICE LOT #: 2024137, MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, DEVICE MANUFACTURE DATE: 24-JAN-2022. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. IT WAS REPORTED THAT AT LEAST ONE BD SAFETYGLIDE¿ NEEDLE EACH FROM LOTS 0269691, 2003405 AND 2024137 WERE BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS FACILITY NOW HAS AFFECTED NEEDLES" D.4. MEDICAL DEVICE EXPIRATION DATE: 30SEP2025. H.4. DEVICE MANUFACTURE DATE: 25SEP2020. INVESTIGATION SUMMARY: FOURTEEN SAMPLES FROM LOT 2003405, ONE SAMPLE FROM LOT 0269691 AND THREE LOOSE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. NO SAMPLES WERE RETURNED FROM LOT NUMBER 2024137. UPON VISUAL INSPECTION, NO DEFECTS OR ISSUES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW, CLOGGED NEEDLE WAS NOT CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2003405, 2024137 AND 0269691. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST ONE BD SAFETYGLIDE¿ NEEDLE EACH FROM LOTS 2003405 AND 2024137 WERE BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS FACILITY NOW HAS AFFECTED NEEDLES"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST ONE BD SAFETYGLIDE¿ NEEDLE EACH FROM LOTS 0269691, 2003405 AND 2024137 WERE BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS FACILITY NOW HAS AFFECTED NEEDLES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302774 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 0269691 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown