BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SPINAL NEEDLE 27GA 3.50 IN

    MDR report key: 12202290 · Received July 21, 2021

    Report

    Report Number
    3003152976-2021-00409
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 22, 2021
    Report Date
    July 5, 2021
    Product Code
    BSP
    PMA / PMN Number
    K091758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE LABEL IS OBSERVED TO BE MISSING FROM THE CASE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2003002, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCTS UNDERGO VISUAL AND FUNCTIONAL INSPECTIONS ACCORDING TO PROCEDURE. ALL RESULTS WERE REVIEWED FOR LOT 2003002 AND NO ISSUES WERE IDENTIFIED. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THE ROOT CAUSE OF THIS INCIDENT IS DUE TO OPERATOR ERROR AS THE LABEL IS MANUALLY PLACED ONTO THE CASE. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABEL IS MISSING FROM PACKAGING WITH A BD SPINAL NEEDLE 27GA 3.50 IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO CATALOG. NO PRODUCTION DATE. NO DATE EXPIRY. NO LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099899 BD SPINAL NEEDLE 27GA 3.50 IN NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP 2003002

    Patients

    Seq Age Sex Outcome Treatment
    1