BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DUAL PORT WITH Q-SYTE

    MDR report key: 15287115 · Received August 24, 2022

    Report

    Report Number
    1710034-2022-00450
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    July 28, 2022
    Report Date
    November 7, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835324
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED AN UNUSED AND PARTIALLY RETRACTED 22G X 1.00IN. NEXIVA UNIT FROM LOT NUMBER 1193064. THE END OF THE TIP SHIELD AND THE NEEDLE INSIDE IT APPEAR TO BE BENT. ADDITIONALLY, THE GRIP IS SLIGHTLY ANGLED AND DOES NOT PROPERLY SIT ON THE TIP SHIELD. THE BENT COMPONENTS WOULD PREVENT THE NEEDLE FROM FULLY RETRACTING AND DECOUPLING FROM THE CATHETER ADAPTER, THEREFORE, YOUR REPORTED ISSUE IS CONFIRMED. ALTHOUGH THE FAILURE STATED IN THE REPORTED ISSUE WAS CONFIRMED WITH THE PHOTOGRAPH PROVIDED FOR INVESTIGATION, BD COULD NOT ESTABLISH A DEFINITE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA DUAL PORT WITH Q-SYTE SAFETY MECHANISM WILL NOT DISENGAGE FROM CATHETER AND STUCK AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING CANNULATION WITH NEXIVA 22 GA, THE SAFETY STYLET DID NOT COME OUT FROM THE HUB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA DUAL PORT WITH Q-SYTE SAFETY MECHANISM WILL NOT DISENGAGE FROM CATHETER AND STUCK AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING CANNULATION WITH NEXIVA 22 GA, THE SAFETY STYLET DID NOT COME OUT FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2324152 BD NEXIVA DUAL PORT WITH Q-SYTE INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1193064 00382903835324

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown