BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE

    MDR report key: 21019274 · Received December 26, 2024

    Report

    Report Number
    2618282-2024-00193
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    December 13, 2024
    Report Date
    January 24, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    BSP
    UDI-DI
    00382904051808
    PMA / PMN Number
    K210978
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, 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.

    Description of Event or Problem · 0

    MATERIAL#: 405180, BATCH NUMBER#: 4211030. VERBATIM#: A DOCTOR WAS USING BD NEEDLES, REF# 405180, AND FOUND THE NEEDLES TO BE CLOGGED. SHE TRIED SEVERAL AND THEY DID NOT WORK AND CHECKED THE SYRINGES WHICH WERE OK. THE FAULTY ONES WERE IN LOT # 4211030. WE HAVE 21 UNOPENED NEEDLES FROM ONE OPENED BOX. WE HAVE 6 MORE BOXES OF 25 UNOPENED OF THAT SAME LOT NUMBER. NO PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2494413 NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP BECTON DICKINSON 4211030 00382904051808

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown