BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12952646 · Received December 7, 2021

    Report

    Report Number
    9610847-2021-00581
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    September 22, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K173354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO PHOTOS OR SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMALL HOLE IN THE BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM PLASTIC HOSE CAUSED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "NEWLY INSTALLED PVK WITH FAULT ON PLASTIC HOSE, LEAKY. 22/9 THE PATIENT BECOMES RESPIRATORY ILL, THAT IS NEED FOR CONSTRUCTION OF ADDITIONAL PVK. THERE IS CLINICAL RAISED SUSPICION OF LE, THEREBY SEEKING CONSTRUCTION OF MINIUM PVK OF SIZE PINK AS WITHSTANDS CONTRAST. CONSTRUCTION ACCORDING TO CLINICAL GUIDELINE, AS THE NEEDLE IS PULLED BACK IT IS SEEN THAT THERE IS A SMALL HOLE IN IT PLASTIC - THE HOSE, WHEREBY PVK ALREADY V. CONSTRUCTION IS LEAKY - LIGHT BLEEDING. PVK MUST DESPITE CORRECT PLANT IS DISCONTINUED. PRIOR TO THE ABOVE ATTEMPTED ON CONSTRUCTION OF PVK, ALREADY STUCK 2 TIMES V. OTHER NURSE, DUE TO DEFECTS IN THE PRODUCT MAY THE PATIENT IS STABBED A TOTAL OF 4 TIMES BEFOREHAND WELL-FUNCTIONING PVK IS LANDSCAPED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848215 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 1053976

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown