BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SPINAL S/SU 22GA 3-1/2IN QUINCKE

    MDR report key: 21056125 · Received January 2, 2025

    Report

    Report Number
    2618282-2024-00195
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 10, 2024
    Report Date
    January 23, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    BSP
    UDI-DI
    00382904051815
    PMA / PMN Number
    K210978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THREE (3) 22GA X 3.5¿ UNUSED AND SEALED NEEDLES FOR BATCH NUMBER 4123761 WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLES WERE SUBMITTED FOR VISUAL INSPECTION FIRST. THERE WAS NO POINT DAMAGE, INCLUDING HOOKS, SWAGE MARKS, SCRATCHES, INCOMPLETE OR OPEN POINTS, UNSMOOTH GROUND SURFACES, DISCOLORATION OF ANY KIND OR SILVERS, AND NO PROTRUDERS, NO RECEDERS. THE NEEDLES WERE ALSO SUBMITTED TO TEST FOR ANY CLOGS OR BLOCKAGES. THE SAMPLES COMPLY WITH THE EXPECTED CHARACTERISTICS AND THE REPORTED FAILURE WAS NOT OBSERVED IN THE NEEDLES; THEREFORE, THE REPORTED FAILURE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED AS THE INCIDENT COULD NOT BE VERIFIED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL# 405181 BATCH# 4123761 VERBATIM: I HAVE A HANDFUL OF THESE NEEDLES. REF 405181 22G X 3.50¿ LOT# 4123761 I AM TOLD THAT THESE HAVE BEEN ¿CLOGGING UP¿ WHEN BEING USED. THREE DIFFERENT STAFF MEMBERS HAVE STATED THIS. ADDITIONAL INFORMATION: DEC 20 IT HAPPENED MULTIPLE TIME (3+) FOR 3 DIFFERENT RADIOLOGISTS ON 3 DIFFERENT DAYS. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375003 NEEDLE SPINAL S/SU 22GA 3-1/2IN QUINCKE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP BECTON DICKINSON 4123761 00382904051815

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown