BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML LL

    MDR report key: 21835521 · Received April 14, 2025

    Report

    Report Number
    1213809-2025-00271
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 25, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    (B)(4). SUPPLEMENTAL MDR - SYRINGE NEEDLE CONNECTIVITY ISSUE. ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION, NO DEFECTS WERE OBSERVED ON THE SYRINGE PROVIDED. A NEEDLE WAS ATTACHED TO THE SYRINGE, AND NO CONNECTIVITY ISSUES WERE OBSERVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3041968. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML LL HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. "HCP CALLED (B)(6) TO ASK, "I NEED TO GET THIS IZERVAY REPLACED? SOMETHING HAPPENED TO IT WHEN THE DOCTOR WENT TO GIVE IT". WHEN PRESSED FOR FURTHER INFORMATION THE HCP STATED, "WHEN THE DOCTOR WENT TO USE IT THE SYRINGE POPPED OFF AS SHE WAS GETTING THE AIR BUBBLES OUT". THE MEDICATION WAS NOT GIVEN TO A PATIENT, " IT JUST HAPPENED - I HAVE IT IN MY HAND IT'S ALL TAPED UP AND BOXED. I KNEW YOU WERE GOING TO ASK ME QUESTIONS ABOUT IT SO I MADE SURE TO HAVE EVERYTHING READY FOR YOU."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425322 BD SYRINGE 1ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3041968 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown