BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD QUINCKE¿ SPINAL NEEDLE

    MDR report key: 15946988 · Received December 8, 2022

    Report

    Report Number
    3003152976-2022-00546
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 17, 2022
    Report Date
    January 31, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    BSP
    PMA / PMN Number
    K210078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 13-DEC-2022. H6: INVESTIGATION SUMMARY ONE PHOTO, THE IMPACTED SAMPLE, AND TEN UNUSED SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION OF THE PHOTO, THE STYLET IS SHOWN TO BE BENT. THE PHYSICAL SAMPLE AND UNUSED SAMPLES WERE EVALUATED USING MAGNIFICATION, NO DAMAGE OR DEFECTS WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED AND NO FRICTION IDENTIFIED, THE COMPONENTS COULD BE SEPARATED WITHOUT ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2010010, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS THE ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION THE NEEDLE IS FREE FROM DAMAGE OR DEFECTS AND ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. ALL INSPECTIONS FOR LOT 2010010 WERE COMPLETED ACCORDING TO PROCEDURE, NO ANNOTATIONS WERE NOTED RELATED TO THE REPORTED INCIDENT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED BY THE CUSTOMER THAT 3 OF THE BD QUINCKE¿ SPINAL NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: UPDATE ON 25TH NOV 2022 AS AGREED, I AM SENDING THE PHOTOGRAPH OF THE NEEDLE BROKEN AT THE BASE AND THE ANGLED MANDREL. THE PRODUCT WAS NOT USED ON THE PATIENT. --------------------- WHEN THE DEVICE IS OPENED, THE NEEDLE AND THE STYLET AT THE BASE OF THE HANDLE BREAK. DURING THE SLIDING MOVEMENT OF THE STYLET IN THE NEEDLE, CONSIDERABLE FRICTION IS OBSERVED, RESULTING IN NON-REVERSIBLE ANGULATION OF THE STYLET. THIS NOBILISATION TEST (A ROUTINE MANEUVER THAT IS PERFORMED BEFORE USE ON THE PATIENT) WAS PERFORMED ON AT LEAST 3 PIECES FOUND TO HAVE THE SAME PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT 3 OF THE BD QUINCKE¿ SPINAL NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: UPDATE ON 25TH NOV 2022. AS AGREED, I AM SENDING THE PHOTOGRAPH OF THE NEEDLE BROKEN AT THE BASE AND THE ANGLED MANDREL. THE PRODUCT WAS NOT USED ON THE PATIENT. WHEN THE DEVICE IS OPENED, THE NEEDLE AND THE STYLET AT THE BASE OF THE HANDLE BREAK. DURING THE SLIDING MOVEMENT OF THE STYLET IN THE NEEDLE, CONSIDERABLE FRICTION IS OBSERVED, RESULTING IN NON-REVERSIBLE ANGULATION OF THE STYLET. THIS NOBILISATION TEST (A ROUTINE MANEUVER THAT IS PERFORMED BEFORE USE ON THE PATIENT) WAS PERFORMED ON AT LEAST 3 PIECES FOUND TO HAVE THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2542667 BD QUINCKE¿ SPINAL NEEDLE ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 2010010

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown