BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML S/T SSU NRFIT

    MDR report key: 20768678 · Received November 24, 2024

    Report

    Report Number
    1213809-2024-00877
    Event Type
    Malfunction
    Date Received
    November 24, 2024
    Date of Event
    October 23, 2024
    Report Date
    February 6, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    QEH
    UDI-DI
    00382904000516
    PMA / PMN Number
    K192538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ONE SAMPLE OF A 5 ML S/T SSU NRFIT SYRINGE (PART NUMBER 400051, BATCH 3117599) WAS RECEIVED FOR INVETSIGATION. THE SAMPLE ARRIVED LOOSE AND FULLY ASSEMBLED. UPON INSPECTION, IT WAS OBSERVED THAT THE STOPPER WAS SIGNIFICANTLY DISTORTED, WHICH COMPROMISES THE FUNCTIONALITY AND RELIABILITY OF THE SYRINGE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE POTENTIAL ROOT CAUSE FOR THE DISTORTED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML S/T SSU NRFIT STOPPER WAS DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE USE, WHEN THEY TOOK THE SYRINGE OUT OF THE PACKAGE AND WERE ABOUT TO DRAW UP THE MEDICINE, THEY SAW THAT THE BLACK MEMBRANE LOOKED "MELTED" AND LAY AT AN ANGLED ANGLE INTO THE SYRINGE. THEY NEVER HAD TIME TO USE THE SYRINGE BUT SAW THE DEFECT BEFORE THE DRUG BEGAN TO BE WITHDRAWN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2213881 BD SYRINGE 5ML S/T SSU NRFIT PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT QEH BECTON DICKINSON MEDICAL SYSTEMS 3117599 00382904000516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown