BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 19085047 · Received April 10, 2024

    Report

    Report Number
    1710034-2024-00311
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 20, 2024
    Report Date
    May 22, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835171
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383517 AND LOT NUMBER 3234047. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED BEYOND THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEFECTIVE 20 GA NEXIVA IV CATHETER. IT LEAKED OUT OF THE BACKSIDE AFTER THE STYLET WAS REMOVED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232027 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234047 00382903835171

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown