BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 11234151 · Received January 26, 2021

    Report

    Report Number
    1710034-2021-00058
    Event Type
    Malfunction
    Date Received
    January 26, 2021
    Date of Event
    January 5, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835393
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383539 BATCH NO.: 0241573. BLOOD LEAKING FROM BASE OF IV CATHETER. NEAR GRAY STOPPER.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383539, BATCH NO.: 0241573. BLOOD LEAKING FROM BASE OF IV CATHETER. NEAR GRAY STOPPER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129867 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0241573 00382903835393

    Patients

    Seq Age Sex Outcome Treatment
    1