BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8187311 · Received December 20, 2018

    Report

    Report Number
    1710034-2018-00952
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    December 12, 2018
    Report Date
    March 8, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835196
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DURING DHR REVIEW 1 NON-RELATED QN WAS INITIATED DURING PRODUCTION. ALL OTHER CHALLENGE, SET UP AND IN-PROCESS SAMPLES WERE PERFORMED AND PASSED PER SPECIFICATIONS. RECEIVED 2 NEXIVA 18GA UNITS AS FOLLOWS: ONE USED CATHETER-ADAPTER EXTENSION SET ASSEMBLY WRAPPED AROUND MEDICAL GAUZE AND TAPE WITH A NEEDLELESS CONNECTOR ATTACHED TO THE STRAIGHT ADAPTER AND A FULL ASSEMBLY WITHIN A SEALED PACKAGE FROM LOT NUMBER 8232654. VISUAL EXAMINATION: USED UNIT: TRACES OF PATIENT RESIDUE WAS OBSERVED THROUGHOUT THE COMPONENTS OF THE CATHETER-ADAPTER ASSEMBLY RECEIVED. THE EXTENSION TUBING WAS DISCONNECTED FROM THE PORT OF THE WINGED ADAPTER. TRACES OF ADHESIVE RESIDUE WERE PRESENT ON THE OUTER RIM OF THE WING ADAPTER PORT. UNUSED UNIT: NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE UNITS RECEIVED. THE EXTENSION TUBINGS WERE PROPERLY ADHERED TO THE WALL OF THE WINGED ADAPTERS THE EXTENSION TUBINGS WERE MANUALLY PULLED IN AN ATTEMPT TO DISCONNECT IT FROM THE WINGED ADAPTER. THE TUBINGS STAYED CONNECTED AND DID NOT DISLODGED. THE FAILURE MODE OF DETACHED EXTENSION TUBING WAS CAUSED BY AN INSUFFICIENT AMOUNT OF ADHESIVE DISPENSED TO FULLY BOND THE TUBING TO THE CATHETER ADAPTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING IS COMING OFF OF BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING IS COMING OFF OF BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024108 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8232654 30382903835196

    Patients

    Seq Age Sex Outcome Treatment
    1 Other