BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INV - NEXIVA 20GA 1.00IN HF Y

    MDR report key: 19531748 · Received June 13, 2024

    Report

    Report Number
    1710034-2024-00596
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 22, 2024
    Report Date
    July 24, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION FINDINGS: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED 20GX1.00IN NEXIVA DEVICE FROM LOT NUMBER 4030906. A GROSS VISUAL INSPECTION OF THE RETURNED COMPONENT SHOWS THE UNIT HAS BEEN USED. THE NEEDLE GRIP IS MISSING, AND THE NEEDLE IS BROKEN AT THE END OF THE GREY CANISTER. ALTHOUGH THE NEEDLE APPEARS USED, THE DECOUPLING PROCESS HAS NOT BEEN PERFORMED. PER YOUR VERBATIM IN YOUR REPORT, THE NEEDLE WOULD NOT RELEASE FROM THE CATHETER. THE RETURNED UNIT WAS INVESTIGATED BY WIGGLING THE CATHETER ASSEMBLY OUT OF THE TIP SHIELD. UPON REMOVAL, A HOLE WITH A TEAR DROP SHAPE IN THE TIP SHIELD WAS OBSERVED. YOUR REPORTED ISSUE WAS CONFIRMED. THIS DAMAGE IS LIKELY TO OCCUR DURING MANUFACTURING PROCESS WHILE INSERTING THE CANNULA INTO THE GRIP AND TIP SHIELD. THE MISALIGNMENT CREATED A FLASH IN THE TIP SHIELD THE PREVENT THE CATHETER ADAPTER TO RELEASE AND SIMULTANEOUSLY MAKE IT DIFFICULT OF NEEDLE DECOUPLING. THE DEFECT OF BROKEN NEEDLE WAS LIKELY CAUSED BY THE USER AS DECOUPLING WAS NOT OCCURRING. OPERATORS PERFORM IN PROCESS SAMPLING AND TESTING FOR DECOUPLING THROUGHOUT THE MANUFACTURING PROCESS TO MITIGATE THE OCCURRENCE OF THIS TYPE OF DEFECT. DURING THE PROCESS SAMPLING OF THIS LOT, A FAILURE TO DECOUPLE ISSUE OR NEEDLE DISENGAGEMENT DIFFICULTY WERE NOT FOUND. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL #: 383536 BATCH #: 4030906 IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE RETRACTION DEVICE WOULD NOT RELEASE FROM THE CATHETER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AFTER INSERTION OF THE NEXIVA 20 GA, THE NEEDLE RETRACTION DEVICE WOULD NOT RELEASE FROM THE CATHETER. PRODUCT WAS OBTAINED WITH PACKAGING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766714 INV - NEXIVA 20GA 1.00IN HF Y CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4030906 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown