BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15744102 · Received November 7, 2022

    Report

    Report Number
    1710034-2022-00658
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    October 12, 2022
    Report Date
    November 8, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835379
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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¿ CLOSED IV CATHETER SYSTEM BECAME LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: INJECTION MEMBRANE (Q-SITE) ON PVK WHICH SHOULD BE SCREWED ON BUT WAS NOT ATTACHED AND CAME LOOSE SO THAT THE NURSE'S SHOES AND CLOTHES BECAME BLOODIED. THE SHOES HAD TO BE THROWN AWAY. IT HAS HAPPENED REPEATEDLY THAT THE MEMBRANES ARE NOT ATTACHED PROPERLY AND COME OFF WHEN SAMPLING OR FLUSHING THE PVK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM BECAME LOOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SWEDISH TO ENGLISH: INJECTION MEMBRANE (Q-SITE) ON PVK WHICH SHOULD BE SCREWED ON BUT WAS NOT ATTACHED AND CAME LOOSE SO THAT THE NURSE'S SHOES AND CLOTHES BECAME BLOODIED. THE SHOES HAD TO BE THROWN AWAY. IT HAS HAPPENED REPEATEDLY THAT THE MEMBRANES ARE NOT ATTACHED PROPERLY AND COME OFF WHEN SAMPLING OR FLUSHING THE PVK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212392 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2028065 00382903835379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown