BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT

    MDR report key: 19417228 · Received May 29, 2024

    Report

    Report Number
    1710034-2024-00504
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    May 7, 2024
    Report Date
    May 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383517 AND LOT NUMBER 3234046. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT CATHETER LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BLOOD IS COMING OUT THROUGH THE TIP OF THE CATHETER AND WE HAVE TO START INSTALLATION OF THE CATHETER AGAIN, BECAUSE IT IS NON-FUNCTIONAL. ORIGINAL FRENCH TRANSLATION: LE SANG SORT PAR LE BOUT DU CATHÉTER ET ON DOIT RECOMMENCER L'INSTALLATION DU CATHÉTER, CAR IL EST NON-FONCTIONNEL. THE INCIDENT INVOLVED THE PATIENT, BECAUSE WITH THE PROBLEM WITH THE NEEDLE, WE HAD NO OTHER SOLUTION THAN TO TRANSPLANT THE PATIENT WITH A NEW NEEDLE, SO IT INVOLVED A DOUBLE PRICK FOR THE PATIENT. IN ADDITION, THE INCIDENT INVOLVED THE USER, AS THE BLOOD WAS COMING OUT OF THE NEEDLE, SO THE USER IS IN CONTACT WITH THE PATIENT'S BLOOD. THE MAIN CONSEQUENCE ON THE PATIENT IS THAT WE NEEDED TO TRANSPLANT HIM A SECOND TIME, IN ORDER TO INSTALL AN ADEQUATE AND NON-DEFECTIVE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611006 BD NEXIVA 20 GA X 1-1/4 IN SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown