BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17853854 · Received October 2, 2023

    Report

    Report Number
    1710034-2023-01144
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    September 12, 2023
    Report Date
    November 21, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO 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.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THERE WAS LEAKAGE AT THE SEPTUM. REPORT 2 OF 2. THE FOLLOWING WAS TRANSLATED FROM PORTUGESE TO ENGLISH: WE OPENED AN RO LAST MONTH REGARDING CARE PROVIDED TO A PATIENT WHO CAME TO UNDERGO CHEST CT ANGIOGRAPHY. WHEN PUNCTURING WITH A VENOUS CATHETER, PERFORMED IN LEFT UPPER LIMB, THERE WAS A DEFECT WHEN INJECTING CONTRAST, WHICH WAS IRRIGATED TO ANOTHER CATHETER ROUTE. THE REFLUX VALVE WAS REPLACED TWICE, THE AVP TEST WAS CARRIED OUT BY MORE THAN ONE PROFESSIONAL WHO FOUND THAT IT WAS PATENT AND EVEN SO, WHEN TRYING TO CARRY OUT A NEW ATTEMPT, IT SHOWED THE SAME DEFECT. IT WAS NECESSARY TO ATTEMPT A NEW AVP AND THE PATIENT PRESENTED CAPILLARY FRAGILITY AND DECIDED TO RESCHEDULE AS 04 UNSUCCESSFUL ATTEMPTS WERE MADE. NEXIVA PERIPHERAL CATHETER NUMBER 20G, LOT 2250134, EXPIRATION DATE 08/31/2025. TODAY ((B)(6)23) IT HAPPENED AGAIN WITH ANOTHER PATIENT, BUT WITH A DIFFERENT BATCH NEXIVA PERIPHERAL CATHETER NUMBER 20G, BATCH 1259190, EXPIRATION DATE 09/30/2024. TODAY WE WILL REGISTER ANOTHER RO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977168 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1259190 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown