BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL NEEDLE 27GA 3.50 IN

    MDR report key: 12140087 · Received July 8, 2021

    Report

    Report Number
    3003152976-2021-00371
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1910022, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF LOT 1910022 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WAS OBSERVED ON ANY OF THE PRODUCT. FUNCTIONAL EVALUATIONS WERE PERFORMED, NO FRICTION WAS NOTED DURING THE CONNECTION OF THE SAMPLES AND THE NEEDLE COULD SMOOTHLY ADVANCE THROUGH THE INTRODUCER. DIMENSIONAL TESTING WAS PERFORMED ON THE RETAINED SAMPLES, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION INCLUDING THE INTERNAL DIAMETER OF BOTH THE CANNULA AND THE INTRODUCER. PRODUCT UNDERGOES VISUAL INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS, VERIFYING NO DEFECTS ON THE PRODUCT. INSPECTION RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED. BASED ON OUR INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SPINAL NEEDLE 27GA 3.50 IN WAS CLOGGED. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXPERIENCED DIFFICULTIES WHEN ADMINISTERED ANESTHETIC DRUGS AND TWO OF HIS PATIENT WAS HEMATOMA POST INSERTED BD QUINCKE. OVERALL, THE OPERATIVE PROCEDURE WAS SUCCESS AND PATIENT DISCHARGE AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035002 SPINAL NEEDLE 27GA 3.50 IN NEEDLE FMI BECTON DICKINSON, S.A. 1910022

    Patients

    Seq Age Sex Outcome Treatment
    1