BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 15564130 · Received October 7, 2022

    Report

    Report Number
    1213809-2022-00689
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    August 4, 2022
    Report Date
    October 10, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE HUNDRED SAMPLES FROM LOT 2024138 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. NO SAMPLES WERE RETURNED FROM LOT NUMBER 2010821. FIFTY SAMPLES WERE RANDOMLY SELECTED FOR EVALUATION. UPON VISUAL INSPECTION, NO DEFECTS OR ISSUES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, EACH SAMPLE WAS CONNECTED TO A SYRINGE WITH SALINE SOLUTION. FIVE SAMPLES DID NOT EXPEL THE SOLUTION, THESE NEEDLES ARE CLOGGED. THIS DEFECT COULD OCCUR IF THERE WAS A PROCESS VARIATION DURING THE LUBRICATION APPLICATION PROCESS INDUCING THE SYMPTOM REPORTED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 2024138 AND 2010821. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE LUBRICANT APPLICATION PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND THE FLOW OF PRODUCTS WAS GOOD. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT 25 BD SAFETYGLIDE¿ NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OFFICES ARE REPORTING THAT THEY ARE UNABLE TO PUSH MEDICATION/VACCINE OUT OF THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 25 BD SAFETYGLIDE¿ NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OFFICES ARE REPORTING THAT THEY ARE UNABLE TO PUSH MEDICATION/VACCINE OUT OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419398 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2024138 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown