BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8104246 · Received November 26, 2018

    Report

    Report Number
    1710034-2018-00847
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 5, 2018
    Report Date
    December 7, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835165
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLE, BATCH OR LOT CODE WAS PROVIDED. THIS COMPLAINT WILL BE ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED & TRENDED FOR FUTURE OCCURRENCES. SHALL A SAMPLE OR LOT NUMBER BECOME AVAILABLE, THE COMPLAINT WILL BE RE-OPENED AND AN INVESTIGATION WILL TAKE PLACE. THIS COMPLAINT WILL BE CLOSED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA CLOSED IV CATHETER SYSTEM EXTENSION TUBING DISCONNECTED FROM THE HUB.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT # [8142584] WAS NOT FOUND FOR THE REPORTED CATALOG # [383516]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXTENSION TUBING DISCONNECTED FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940352 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 30382903835165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other