BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G

    MDR report key: 15700069 · Received October 31, 2022

    Report

    Report Number
    1213809-2022-00830
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 5, 2022
    Report Date
    October 7, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: THIRTY-EIGHT SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. 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 NUMBER 2024138. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PROBABLE ROOT CAUSE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G THE NEEDLE WAS CLOGGED. THIS OCCURRED 5 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER NEEDLE CLOGGED/BLOCKED. CAN YOU CONFIRM THE NUMBER OF OCCURRENCES IN THIS EVENT? MORE THAN 5 TIMES FROM PRODUCT REF 305916 LOT 2024138.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2455789 BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2024138 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown