BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18477539 · Received January 9, 2024

    Report

    Report Number
    1710034-2023-01519
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 19, 2023
    Report Date
    February 29, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835172
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: 1. DATE OF EVENT: (B)(6) 2023. 2. DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? DIRECTLY INVOLVED A PATIENT AND A USER. 3. KINDLY CONFIRM THE FINAL RESPONSE NEEDED AS A EMAIL/CLOSURE LETTER? IMPROVEMENTS IN QUALITY TESTING AT THE MANUFACTURER TO ALLEVIATE THE MULTIPLE REPORTED ISSUES IN 2023 WOULD BE GREAT! 4. PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR DOCUMENTATION. (B)(6). 1. STATED THAT 3 SAMPLES OF THE SAME PRODUCT NUMBERS WERE REMOVED FROM THE SHELF, DID NOT STATE THAT THE INCIDENT OCCURRED WITH THOSE OTHER DEVICES. PLEASE CONFIRM REGARDING THIS A. THE COMPLAINT FILED WAS THAT THIS SITUATION HAPPENED WITH 3 IVS WITH THE SAME LOT # AND THE SAME PROBLEM. 2. DID THE OTHER DEVICES THAT WERE REMOVED FROM THE SHELVES EXPERIENCE ANY ISSUES OR WERE THEY REMOVED IN PRECAUTION? WAS THERE ANY PATIENT HARM? A. YES, THEY ALL LEAKED BLOOD AT THE BACK OF THE IV SYSTEM AFTER THE NEEDLE WAS REMOVED. THESE WERE NOT REMOVED FROM THE SHELF AS A PRECAUTION. PATIENT HARM IN ALL 3 INSTANCES SINCE EACH PATIENT REQUIRED A SECOND IV PLACEMENT DUE TO THE FAILURE OF THE FIRST DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM LEAKED. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: THE SYSTEM IS LEAKING BLOOD AT THE GRAY STOPPER ONCE THE NEEDLE IS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553621 NEXIVA 20 GA X 1-1/4 IN SINGLE PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234046 30382903835172

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown