BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15090052 · Received July 22, 2022

    Report

    Report Number
    9610847-2022-00271
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 23, 2022
    Report Date
    August 9, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903835929
    PMA / PMN Number
    K173354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). 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

    G5: CORRECTED 510K NUMBER K123734 TO K173354 H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 2 REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF DISCOLORATION WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. BOTH SAMPLES WERE VISUALLY INSPECTED, AND ONE OF THE TWO SAMPLES SHOWED DISCOLORATION. BD DETERMINED THAT THE CAUSE OF THE DISCOLORATION CAN BE ASSOCIATED TO OUR LASER CUTTING PROCESS DURING MANUFACTURING. THE DISCOLORATION IS SLIGHT BURNING OF THE MATERIAL DUE TO THE HEAT FROM THE CUTTING LASER. HOWEVER, THE AMOUNT OF DISCOLORATION FOUND WAS ACCEPTABLE BASED OFF OUR MANUFACTURING STANDARDS. 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 THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER, TIP IS DISCOLORED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DISCOLORATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER, TIP IS DISCOLORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560999 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383592 2090066 30382903835929

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown