BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SPINAL NEEDLE QUINCKE TYPE POINT

    MDR report key: 12147801 · Received July 9, 2021

    Report

    Report Number
    3003152976-2021-00386
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICALS SAMPLES THAT DISPLAY THE REPORTED ISSUE WERE PROVIDED FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER 2007006 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. FIVE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS INSPECTED USING MAGNIFICATION, NO DAMAGE OR MOLDING DEFECTS WERE OBSERVED. PRODUCT IS VISUALLY AND FUNCTIONALLY TESTED THROUGHOUT MANUFACTURING ACCORDING TO PROCEDURE. RESULTS WERE REVIEWED FOR LOT 2007006, NO ISSUES RELATED TO T HE ALLEGED DEFECT WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. INVESTIGATION CONCLUSION: NO SAMPLES NOR PICTURES HAVE BEEN RECEIVED FOR THE INVESTIGATION. ON (B)(6) 5 RETAINED SAMPLES WERE RECEIVED FOR TESTING. A 10X VISUAL INSPECTION WAS PERFORMED AND NO COMPLAINT RELATED DEFECTS WERE FOUND AND NO OTHER DEFECTS WERE FOUND. NO MAINTENANCE INCIDENTS OR NON-CONFORMITIES RELATED TO THE COMPLAINT DEFECT WERE RECORDED DURING THE REVIEW OF DHR FOR LOT 2007006, PRODUCT 405120. THE DHR OF THE ASSEMBLY REF: (B)(4) LOTS 0182290 AND 0164429 HAVE BEEN REVIEWED AND FOUND NO MAINTENANCE INCIDENTS OR NON-CONFORMITIES RELATED TO THE COMPLAINT DEFECT. DURING ASSEMBLY PROCESS, BETWEEN THE CANNULA AND STYLET SEVERAL INSPECTIONS ARE CARRIED OUT ACCORDING TO (B)(4)(CURRENT VERSION) TO AVOID DEFECTS IN SPINAL NEEDLES. IT IS CHECKED THAT THE STILETTO IS EASY TO REMOVE FROM THE CANNULA AND THAT THE SPINAL NEEDLE HAS NO DEFECTS (NICKS, PARTICLES, BENT TIPS, ETC). SPINAL NEEDLES ARE EVALUATED WITH A 10X BINOCULAR. ACCORDING TO INSPECTION PLAN PROCEDURE (B)(4), PACKAGES ARE SAMPLED AT THE BEGINNING, AT THE MIDDLE AND AT THE END OF THE PALLET BEING SUBJECTED TO VISUAL INSPECTIONS IN SECONDARY PACKAGING. IN ADDITION, ACCORDING TO THE QUALITY INSPECTIONS OF SPINAL NEEDLES PROCEDURE (B)(4), FOUR (4) PACKAGES FOR EACH PALLET ARE SAMPLED TO BEING SUBJECTED TO VISUAL INSPECTIONS INCLUDING INCORRECT QUANTITY OF UNITS OR EMPTY PACKAGE. THEREFORE, AS NO INCIDENCES WERE RECORDED DURING DHR REVIEW NOR LOT RELEASE TESTING, AND NO SAMPLES NOR PICTURES WERE RECEIVED, ROOT CAUSE CANNOT BE CONFIRMED. 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 QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD¿ SPINAL NEEDLE QUINCKE TYPE POINT EXPERIENCED SEPARATION BETWEEN THE NEEDLE AND MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONNECTING LOCK SYSTEM WAS NOT PROPER. THE PRODUCT AFTER REMOVAL WAS NOT GETTING LOCKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039331 BD SPINAL NEEDLE QUINCKE TYPE POINT NEEDLE FMI BECTON DICKINSON, S.A. 2007006

    Patients

    Seq Age Sex Outcome Treatment
    1