BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ NEEDLES

    MDR report key: 7321460 · Received March 7, 2018

    Report

    Report Number
    3002682307-2018-00043
    Event Type
    Malfunction
    Date Received
    March 7, 2018
    Date of Event
    February 10, 2018
    Report Date
    April 2, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: "RETURNED SAMPLE EVALUATION" PICTURE SHOW A BROKEN HUB (PINK PLASTIC PART) AT THE LEVEL OF THE INJECTION POINT. "LOT NUMBER / PRODUCT FAMILY HISTORY" COMPLAINT TRENDING REVIEW OF THIS LOT AND PRODUCT FAMILY FOR THIS ISSUE REVEALS NO MORE COMPLAINTS. "DHR/BHR REVIEW", "ALL THE PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S WERE FOUND. NEEDLES WERE PACKED IN MACHINE 2103 (JUNE 15 -18TH, 2017) DURING WHICH 61 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLES (#7163004 WERE ASSEMBLED IN MACHINE Nº4407 (JUNE 14-21ST, 2017) DURING WHICH 353 VISUAL INSPECTIONS OF 25 UNITS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. RESEARCH HAS NO FOUND ABNORMALITIES IN INJECTED HUB BATCHES #7160096, #7160211 (MACHINE 3570 AND 3548, RESPECTIVELY, IN JUNE, 2017) DURING WHICH 99 VISUAL INSPECTIONS WERE CARRIED OUT." X CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. CUSTOMER COMPLAINT IS RELATED TO BROKEN HUB; UPON EXAMINATE RETURNED PICTURE IS CONFIRM. INVESTIGATION CONCLUSION: ROOT CAUSE "BASED ON ABOVE RESULTS, A BROKEN HUB (PLASTIC PART) ISSUE TOOK PLACE. TAKING INTO ACCOUNT AND AFTER DISCUSSING WITH OUR PRODUCTION TECHNICIANS, THE ISSUE MAY BE PRODUCED IN THE TRAY OF THE HUB FEEDER WHERE HUBS ARE PLACED IN RACKS (A PLASTIC PIECE USED TO MOVE NEEDLES THOUGH THE ASSEMBLED PROCESS). IF ANY HUB HAS SOME INAPPROPRIATE PLACEMENT DUE TO SOME UNEXPECTED MOVEMENT, IT COULD HAVE BEEN ENOUGH DAMAGED TO BREAK ITSELF DURING HANDLING OF THE PRODUCT. IN ACCORDANCE, THIS TRAY HAVE BEEN REPLACED FOR A NEW ONE SINCE IT WAS SLIGHTLY WORN. IN ADDITION, BASED ON OUR QUALITY INSPECTIONS AND THE LIMITED COMPLAINTS RECEIVED RELATED WITH THIS NONCONFORMANCE WE CAN ASSURE THAT THE PROBABILITY OF FINDING THIS ISSUE IN OUR MANUFACTURING PROCESS IS REALLY LOW.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT BEFORE USE, A BD MICROLANCE¿ NEEDLES WAS FOUND WITH THE NEEDLE BROKE DOWN WHILE ¿PREPARING A FLACON OF CANCIDAS WITH NACL.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165516 BD MICROLANCE¿ NEEDLES NEEDLE FMI BECTON DICKINSON, S.A. 170612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other