BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD

    MDR report key: 8461843 · Received March 28, 2019

    Report

    Report Number
    3002682307-2019-00212
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 17, 2019
    Report Date
    April 22, 2019
    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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. BD HAS BEEN PROVIDED WITH 3 SAMPLES OF LOT 190119: 2 DAMAGED HUB (CAV 3U AND 5J) AND 1 BROKEN HUB AT THE LEVEL OF MIDDLE HUB. THE DEFECT IS CONFIRMED. HOWEVER, AFTER DISCUSSING WITH OUR PRODUCTION TECHNICIANS AND BASED ON OUR PREVIOUS EXPERIENCES, THE BROKEN ISSUE COULD NOT BE PRODUCED BEFORE USED: DAMAGED HUB 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, BUT NOT DURING MANUFACTURING STEPS BECAUSE IT SHOULD BE DISCARDED IN THE PACKAGING MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD EXPERIENCED PRODUCT DAMAGE. THE CUSTOMER REPORTED, "THE SERVICE REPORTS THAT SEVERAL NEEDLES AT THE HUB WERE FOUND CRACKED AND/OR BROKEN."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THE NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD EXPERIENCED PRODUCT DAMAGE. THE CUSTOMER REPORTED, "THE SERVICE REPORTS THAT SEVERAL NEEDLES AT THE HUB WERE FOUND CRACKED AND/OR BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253355 NDLE 18GA 1-1/2IN BLT FILL NC TW SHLD NEEDLE FMI BECTON DICKINSON, S.A. 190109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other