BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NEEDLE 27GA 3.50 IN

    MDR report key: 18215517 · Received November 28, 2023

    Report

    Report Number
    3003152976-2023-00516
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    November 6, 2023
    Report Date
    February 12, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    MIA
    UDI-DI
    00382904052591
    PMA / PMN Number
    K091758
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A050401 - FLUID/BLOOD LEAK. PATIENT PROBLEM CODE: F24 - INSUFFICIENT INFORMATION.

    Additional Manufacturer Narrative · 0

    PR 9201341 FOLLOW UP MDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2302024, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON OR NEAR THE LUER CONNECTION. ADDITIONAL EVALUATIONS VERIFIED THE PRODUCTS MET REQUIRED SPECIFICATIONS, THE NEEDLE WAS CONNECTED TO A MATING LUER WITHOUT ISSUE AND NO LEAKAGES OCCURRED. PRODUCT IS VISUALLY AND FUNCTIONALLY TESTED THROUGHOUT MANUFACTURING ACCORDING TO PROCEDURE, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. TESTING RESULTS FOR LOT 2302024 VERIFIED PRODUCT MET ALL REQUIRED LIMITS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    CSF LEAK WHEN CONNECTING A SYRINGE.

    Description of Event or Problem · 0

    CSF LEAK WHEN CONNECTING A SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523676 SPINAL NEEDLE 27GA 3.50 IN NEEDLE, SPINAL, SHORT TERM MIA BECTON DICKINSON 2302024 00382904052591

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown