BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 20875238 · Received December 8, 2024

    Report

    Report Number
    1213809-2024-00926
    Event Type
    Malfunction
    Date Received
    December 8, 2024
    Date of Event
    November 1, 2024
    Report Date
    December 30, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479262598
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    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 - NEEDLE CLOGGED/BLOCKED. THIRTY-EIGHT SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. ALL THE SAMPLES EXPELLED THE SOLUTION WITH NORMAL FLOW, CLOGGED NEEDLE WAS NOT CONFIRMED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 2202914. 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. CORRECTIVE AND PREVENTATIVE ACTIONS HAVE BEEN IMPLEMENTED. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE NEEDLE LUBRICANT APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 306616, LOT # 2202914. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. VACCINE WOULD NOT ADVANCE IN NEEDLE. LOT NUMBER - 2202914. ADDITIONAL INFORMATION PROVIDED: 1) PLEASE PROVIDE DATE OF EVENT? 2)ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 3). PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. 4) ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 1. 11/1/2024. 2. WE HAVE THE BOX OF NEEDLES, BUT THE USED NEEDLE WAS PLACED IN THE SHARPS CONTAINER AFTERWARDS. 3. I DO NOT HAVE A PHOTO OF THE INCIDENT OR THE NEEDLE. I DO HAVE A PHOTO OF THE BOX THE NEEDLE CAME FROM. 4. NO INJURY OR ADVERSE EVENT TO PATIENT OR HEALTHCARE PROFESSIONAL.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488358 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 2202914 10612479262598

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown