BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 19966956 · Received August 12, 2024

    Report

    Report Number
    1710034-2024-00862
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 19, 2024
    Report Date
    July 23, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835171
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF BLOOD LEAKS OUT OF CONTROL PLUG WITH LOT # 3234046 AND MATERIAL # 383517. DHR FOR LOT NUMBER 3234046 HAS BEEN REVIEWED. THIS LOT WAS BUILT AND PACKAGED ON NFA LINE 1 FROM 02SEP2023 THROUGH 06SEP2023 FOR A TOTAL QUANTITY OF (B)(4) UNITS. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND. ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE INFORMATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT BLOOD LEAKS OUT OF BLOOD CONTROL THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: RADIOLOGICAL PUNCTURE OF 20G NEXIVA WITH BLOOD OOZING FROM THE ISOLATION PLUG AFTER PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2200922 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234046 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown