BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9323560 · Received November 14, 2019

    Report

    Report Number
    1710034-2019-01223
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 16, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835189
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS EVENT BUT WITHOUT A SAMPLE NO CORRECTIVE ACTIONS COULD BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    MATERIAL NO.: 383518; BATCH NO.: 9150812. IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD THE METAL NEEDLE COME OFF OF THE RETRACTOR GRIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE TRAVELER RNS SAYS THEY WERE USING A 20GA 1.75INCH NEXIVA (LOT 9150812) AND THE METAL NEEDLE CAME OFF OF THE RETRACTOR GRIP. I HAVEN'T HAD AN ISSUE BUT WE DO HAVE A LOT OF THAT LOT IN STOCK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 383518, BATCH NO.: 9150812. IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HAD THE METAL NEEDLE COME OFF OF THE RETRACTOR GRIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE TRAVELER RNS SAYS THEY WERE USING A 20GA 1.75INCH NEXIVA (LOT 9150812) AND THE METAL NEEDLE CAME OFF OF THE RETRACTOR GRIP. I HAVEN'T HAD AN ISSUE BUT WE DO HAVE A LOT OF THAT LOT IN STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114412 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9150812 30382903835189

    Patients

    Seq Age Sex Outcome Treatment
    1 Other