BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD QUINCKE SPINAL NEEDLE

    MDR report key: 17662789 · Received August 31, 2023

    Report

    Report Number
    3003152976-2023-00364
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 16, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    BSP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTOS PROVIDED DISPLAY LOT 2110029 WHICH HAS A DEEPER ORANGE HUB COLOR AND LOT 2302020 WHICH IS A LIGHTER ORANGE COLOR. BASED ON OUR VISUAL INSPECTION, THE HUB IS OBSERVED TO BE THE CORRECT COLOR FOR EACH LOT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2110029, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. A CHANGE OF THE NEEDLE HUB COLOR WAS IMPLEMENTED AND APPROVED IN SEPTEMBER 2022 FOR 25G NEEDLES TO COMPLY WITH ISO 6009, CHANGING THE COLOR FROM A MORE VIBRANT ORANGE TO BE LIGHTER AS SEEN IN THE PHOTOS PROVIDED. BASED ON THE SAMPLE EVALUATION AND OUR QUALITY TEAM'S INVESTIGATION, NO DEFECT WAS OBSERVED ON THE PRODUCT AS THE CHANGE IN HUB COLOR WAS APPROVED AND IMPLEMENTED AFTER THE MANUFACTURING OF LOT 2110029. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD QUINCKE SPINAL NEEDLE EXPERIENCED INCORRECT COLOR ON DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COLOUR OF THE HUB OF THE NEEDLE IS CHANGE IN DIFFERENT BATCH OF BOTH 23G AND 25G. CUSTOMER'S QUERY IS WHY THERE IS COLOUR CHANGE IN DIFFERENT BATCH OF SAME PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD QUINCKE SPINAL NEEDLE EXPERIENCED INCORRECT COLOR ON DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COLOUR OF THE HUB OF THE NEEDLE IS CHANGE IN DIFFERENT BATCH OF BOTH 23G AND 25G. CUSTOMER'S QUERY IS WHY THERE IS COLOUR CHANGE IN DIFFERENT BATCH OF SAME PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437377 BD QUINCKE SPINAL NEEDLE ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 2110029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown