BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.00IN HF Y

    MDR report key: 11803482 · Received May 10, 2021

    Report

    Report Number
    1710034-2021-00389
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 9, 2021
    Report Date
    June 14, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 0301173, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED A PORTION OF THE EXTENSION TUBING BALLOONING ABOVE THE CLEAR PORT OF THE WINGED ADAPTER PLATFORM. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 20GA 1.00IN HF Y TUBING BALLOONED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383536 BATCH NO.: 0301173. IT WAS REPORTED THAT TUBING WAS STRETCHED AND BLOW UP LIKE A BALLOON. PER COMPLAINT DETAILS RECEIVED: WHEN INJECTING CONTRAST DYE THE MACHINE BEGAN TO SHOW INCREASED PRESSURE SO THE CT TECH STOPPED THE INFUSION AND WENT TO LOOK AT THE SITE. THE TUBING WAS STRETCHED AND BLOWN UP LIKE A BALLOON. THE TECH DISCONTINUED THE IV AND STARTED ANOTHER. NO ADVERSE EFFECT WAS REPORTED ON THE PATIENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 20GA 1.00IN HF Y TUBING BALLOONED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383536, BATCH NO.: 0301173. IT WAS REPORTED THAT TUBING WAS STRETCHED AND BLOW UP LIKE A BALLOON. PER COMPLAINT DETAILS RECEIVED: WHEN INJECTING CONTRAST DYE THE MACHINE BEGAN TO SHOW INCREASED PRESSURE SO THE CT TECH STOPPED THE INFUSION AND WENT TO LOOK AT THE SITE. THE TUBING WAS STRETCHED AND BLOWN UP LIKE A BALLOON. THE TECH DISCONTINUED THE IV AND STARTED ANOTHER. NO ADVERSE EFFECT WAS REPORTED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694644 NEXIVA 20GA 1.00IN HF Y INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0301173 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1