BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21561783 · Received March 10, 2025

    Report

    Report Number
    1911916-2025-00196
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 15, 2025
    Report Date
    March 10, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE NEEDLE CORED THE RUBBER STOPPER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305180 AND LOT NUMBER 4212676. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE 18X1-1/2 BLUNT FILL NEEDLE CORES THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 3 SEPARATE OCCASIONS, I DREW UP SOME MEDS USING A RED, BLUNT FILL NON CORING NEEDLE AND DREW UP WHAT LOOKED LIKE RUBBER STOPPER INTO MY MED. I HAVE NEVER HAD THIS HAPPEN TO ME PRIOR TO THIS EVENT. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE REPORTED. I USED IT ON 2 ONDANSETRON AND ON A LORAZEPAM VIALS. I USED A DIFFERENT NEEDLE EVERY TIME. I PROBABLY WENT IN BETWEEN A 45 AND A 90 DEGREE ANGLE. I DIDN¿T CHANGE ANYTHING IN MY PRACTICE THOUGH. I HAVE BEEN DRAWING UP MEDS FOR 5 YEARS AND NEVER HAD A PROBLEM WITH THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198382 BD NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4212676 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown