BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD WHITACRE¿ SPINAL NEEDLE

    MDR report key: 17477050 · Received August 7, 2023

    Report

    Report Number
    3003152976-2023-00317
    Event Type
    Malfunction
    Date Received
    August 7, 2023
    Date of Event
    June 21, 2023
    Report Date
    July 24, 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
    501

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2110013, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE INSPECTED USING MAGNIFICATION, NO DAMAGE OR DEFECTS WITHIN THE NEEDLE WERE OBSERVED, THE TIPS ARE ALL IN PROPER CONDITION. ADDITIONALLY, IT WAS VERIFIED THE CANNULA WINDOW IS CORRECTLY POSITIONED, THERE IS NO DAMAGE OR BURRS THAT COULD PREVENT PROPER ENTRY. WHITACRE NEEDLES ARE DESIGNED WITH A PENCIL POINT TIP. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO 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 2201005 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD WHITACRE¿ SPINAL NEEDLE HAD SOME BLOCKAGE AT THE TIP OF THE NEEDLE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: NEEDLE NOT SHARP ENOUGH TO PENETRATE THE SKIN, SOME SORT OF BLOCKAGE AT THE TIP OF THE NEEDLE. CUSTOMER REPORTED THAT THE NEEDLE WAS NOT SHARP ENOUGH TO PENETRATE THE SKIN, AND THERE'S SOME SORT OF BLOCKAGE AT THE TIP OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458460 BD WHITACRE¿ SPINAL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 2110013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown