BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 20939199 · Received December 16, 2024

    Report

    Report Number
    1213809-2024-00952
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 13, 2024
    Report Date
    January 28, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059172
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON PHOTO EVALUATION, IT WAS OBSERVED THAT THE TOP PART OF THE NEEDLE WENT THROUGH THE PLASTIC SHIELD. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED IS CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4143704. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WENT THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH: PACKAGED DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327907 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 4143704 30382903059172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown