BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL/EPIDURAL NEEDLES & TRAYS

    MDR report key: 23364430 · Received October 23, 2025

    Report

    Report Number
    9610048-2025-00151
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    September 25, 2025
    Report Date
    November 7, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    BSP
    UDI-DI
    07891463000958
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 401383 AND LOT NUMBER 5141389. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THEM. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ALL DEMOGRAPHIC INFORMATION ON THE REGULATORY DOCUMENT STATES "CONFIDENTIAL".

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION 20-OCTOBER-2025: DUE TO THE OCCURRENCE, WE INFORM THAT: A NOTIFICATION PROCESS WAS OPENED WITH ANVISA 2025.09.005566, AS REQUIRED BY CURRENT LEGISLATION. THE PRODUCT SHOWS CHANGES: CRACKING, BREAKAGE OF THE PRODUCT OR PART OF IT. WAS THE PRODUCT INSPECTED BEFORE USE? - YES DID THE PROBLEM OCCUR BEFORE, DURING, OR AFTER CONTACT WITH THE PATIENT? - DURING WHAT PROCEDURE WAS PERFORMED AND ON WHICH PART OF THE BODY? - LUMBAR SPINE EQUIPMENT USED? - NO. WAS THE PATIENT HARMED? - NO. WAS THE MATERIAL USED UNTIL THE END OF THE PROCEDURE OR WAS IT NECESSARY TO REQUEST A NEW ONE TO COMPLETE IT? - NO, ANOTHER MATERIAL WAS NEEDED. WAS THE MATERIAL USED UNTIL THE END OF THE PROCEDURE OR WAS IT NECESSARY TO REQUEST A NEW ONE TO COMPLETE IT? - NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE KIT CONTAINS TWO NEEDLES. WHEN USING THE 3 ML NEEDLE, IT EXERTED EXCESSIVE PRESSURE WHEN ADMINISTERING THE ANESTHETIC, CAUSING THE NEEDLE TO RICOCHET AND RESULTING IN A MINOR INJURY TO THE PATIENT. WHEN OPTING TO USE THE 5 ML NEEDLE, IT WAS CRACKED, CAUSING THE MEDICATION TO LEAK DURING INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2739739 SPINAL/EPIDURAL NEEDLES & TRAYS NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) BSP BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5141389 07891463000958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown