BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ QUINCKE SPINAL NEEDLE

    MDR report key: 17666845 · Received August 31, 2023

    Report

    Report Number
    3003152976-2023-00366
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 29-AUG-2023 H.6. INVESTIGATION SUMMARY: MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTOS DISPLAY THE MATERIAL INFORMATION AS WELL AS THE DIFFERENCES IN THE HUB COLOR FOR LOT 2210029 AND 2206012. THERE IS NO PHOTO IN WHICH THE SPINAL NEEDLE CAN BE OBSERVED IN ORDER TO EVALUATE AND ANALYZE IF ANY TYPE OF DEFECT IS DETECTED THAT COULD CONTRIBUTE TO ANY DIFFICULTY INSERTING THE NEEDLE AS REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2210029 AND 2206012, 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 23G NEEDLES TO COMPLY WITH ISO 6009, CHANGING THE COLOR FROM A MORE GREEN/TURQUOISE TO BE A DARK BLUE AS SEEN IN THE PHOTO PROVIDED OF LOT 2210029. AS LOT 2206012 WAS MANUFACTURED PRIOR TO THIS IMPLEMENTATION, THE APPROPRIATE COLOR OF THE HUB IS THE GREEN/TURQUOISE AS SHOWN IN THE PHOTO OF THAT LOT. 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 BEFORE THE MANUFACTURING OF LOT 2210029. IN ORDER TO IDENTIFY ANY ISSUE RELATED TO DIFFICULT INSERTION OF THE NEEDLE, RETAINED SAMPLES OF THE REPORTED LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED USING MAGNIFICATION AND NO DEFECTS WERE IDENTIFIED. PRODUCT UNDERGOES A SERIES OF TESTING AND INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. ALL LOT RELEASE TESTING WAS REVIEWED AND FOUND PRODUCT MET REQUIREMENTS, NO ISSUES WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. 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.

    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.

    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: QUINCKE SPINAL NEEDLE 23G COLOUR CODING DIFFERENCE IN DIFFERENT BATCH AND CUSTOMER IS FACING MORE FRICTION WHILE INSERTING THE NEEDLE IN SPINAL 23G.

    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: QUINCKE SPINAL NEEDLE 23G COLOUR CODING DIFFERENCE IN DIFFERENT BATCH AND CUSTOMER IS FACING MORE FRICTION WHILE INSERTING THE NEEDLE IN SPINAL 23G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438824 BD¿ QUINCKE SPINAL NEEDLE ANESTHESIA CONDUCTION NEEDLE BSP BECTON DICKINSON, S.A. 2210029

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown