BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL/EPIDURAL NEEDLES & TRAYS

    MDR report key: 24802272 · Received April 7, 2026

    Report

    Report Number
    9610048-2026-00050
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 19, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    BSP
    UDI-DI
    07891463000958
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. ALL DEMOGRAPHIC INFORMATION ON THE REGULATORY DOCUMENT STATES "CONFIDENTIAL".H.3. 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 SUMMARY: A REVIEW OF THE BATCH HISTORY, NONCONFORMANCE RECORDS, QUALITY NOTIFICATIONS RELATED TO THE REPORTED LOT, AND CORRECTIVE MAINTENANCE RECORDS WAS PERFORMED, AND NO RECORDS WERE IDENTIFIED THAT COULD BE ASSOCIATED WITH THE REPORTED DEFECT. ADDITIONALLY, THIS COMPLAINT DOES NOT INCLUDE SAMPLES OR PHOTOS FOR ANALYSIS, MAKING IT NOT POSSIBLE TO CONFIRM THE REPORTED DEFECT. BASED ON THE INVESTIGATION CONDUCTED TO DATE, IT HAS NOT BEEN POSSIBLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED DEFECT. THE DEFECT WILL CONTINUE TO BE MONITORED THROUGH THE MONTHLY QUALITY DATA ANALYSIS (QDA) MEETINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN OPENING THE TRAY FOR THE ANESTHESIOLOGIST, SHE NOTICED THE PRESENCE OF A FOREIGN BODY IN THE 1ML SYRINGE THAT IS PART OF THE DISPOSABLE SPINAL TRAY KIT, MAKING IT IMPOSSIBLE TO USE. ANOTHER TRAY HAD TO BE OPENED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442863 SPINAL/EPIDURAL NEEDLES & TRAYS NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5293229 07891463000958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown