BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® WHITACRE SPINAL NEEDLE

    MDR report key: 15870531 · Received November 28, 2022

    Report

    Report Number
    3003152976-2022-00535
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    October 24, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2004012, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION, NO DEFECTS WERE OBSERVED ON THE NEEDLE AND THE STYLET COULD BE REMOVED FROM THE SPINAL NEEDLE WITHOUT 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 2004012 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

    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 THAT THE BD® WHITACRE SPINAL NEEDLE EXPERIENCED A LOOSE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MATERIAL IS SUBJECT TO EXTREME BENDING AND MIGHT BREAK INSIDE THE PATIENT¿S BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD® WHITACRE SPINAL NEEDLE EXPERIENCED A LOOSE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE MATERIAL IS SUBJECT TO EXTREME BENDING AND MIGHT BREAK INSIDE THE PATIENT¿S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663706 BD® WHITACRE SPINAL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 2004012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown