BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SPINAL S/SU 27GA 3-1/2IN QUINCKE

    MDR report key: 19329751 · Received May 16, 2024

    Report

    Report Number
    2618282-2024-00039
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 29, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    BSP
    UDI-DI
    30382904050819
    PMA / PMN Number
    K091758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    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 BATCH REPORTED: BATCH: 3100744. BATCH CREATION DATE: 2023-06-13. BATCH EXPIRATION DATE: 2028-09-30 H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    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. BASED ON THE TEAMS INVESTIGATION, BD DEVICES ARE DESIGNED TO BE MOLDED COMPONENTS COMPATIBLE WITH ISO (INTERNATIONAL ORGANIZATION FOR STANDARDIZATION) DIMENSIONS. THEREFORE, IT IS RECOMMENDED TO USE SYRINGES COMPATIBLE WITH ISO STANDARDS. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS.

    Description of Event or Problem · 0

    D SPINAL NEEDLE 27G(CAT NO.405081) LOT: 3100744 EXP.: 3/31/2028 - FOUND FLUID LEAKAGE BETWEEN JOINT BD SPINAL NEEDLE 27G (CAT NO. 405081) LOT 3286308 EXP.9/30/2028 - FOUND FLUID LEAKAGE BETWEEN JOINT. STOP USING THESE LOT NO. CHANGE LOT NO. TO CUSTOMER FOR TRIAL. ADDITIONAL INFORMATION: NO HARM TO PATIENT OR CAREGIVER. 3. THE REPORT INCIDENT NOTICED DURING USE. 4. CSF FLUID LEAK OUT DURING CHANGE SYRINGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546836 NEEDLE SPINAL S/SU 27GA 3-1/2IN QUINCKE NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP BECTON DICKINSON 3286308 30382904050819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown