BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NEEDLE 22GA 3.00 IN

    MDR report key: 12021123 · Received June 17, 2021

    Report

    Report Number
    3002682307-2021-00264
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    April 2, 2021
    Report Date
    July 1, 2021
    Product Code
    BSP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICALS SAMPLES THAT DISPLAY THE REPORTED ISSUE WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 2003016 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS INSPECTED USING MAGNIFICATION, NO DAMAGE OR MOLDING DEFECTS WERE OBSERVED. PRODUCT IS VISUALLY AND FUNCTIONALLY TESTED THROUGHOUT MANUFACTURING ACCORDING TO PROCEDURE. RESULTS WERE REVIEWED FOR LOT 2003015, NO ISSUES RELATED TO THE ALLEGED DEFECT WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPINAL NEEDLE 22GA 3.00 IN LEAKED CONTRAST IODINE PRODUCT DURING A LUMBAR INFILTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "THE THREAD OF THE LUMBAR PUNCTURE NEEDLE WAS DEFECTIVE. LEAKAGE OF THE PCI (CONTRAST IODINE PRODUCT) TO BE INJECTED DURING A LUMBAR INFILTRATION."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPINAL NEEDLE 22GA 3.00 IN LEAKED CONTRAST IODINE PRODUCT DURING A LUMBAR INFILTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE THREAD OF THE LUMBAR PUNCTURE NEEDLE WAS DEFECTIVE. LEAKAGE OF THE PCI (CONTRAST IODINE PRODUCT) TO BE INJECTED DURING A LUMBAR INFILTRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912760 SPINAL NEEDLE 22GA 3.00 IN ANESTHESIA CONDUCTION NEEDLE BSP 2003016

    Patients

    Seq Age Sex Outcome Treatment
    1