BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 20983694 · Received December 19, 2024

    Report

    Report Number
    1710034-2024-01520
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    December 4, 2024
    Report Date
    January 29, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383519 AND LOT NUMBER 4232063. 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 FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT LEAKED AT THE SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RN INSERTED IV, OBTAINED BLOOD RETURN, AND WHILE OULLING BACK TO REMOVE THE NEEDLE FROM THE PRODUCT, BLOOD BEGAN POURING OUT OF THE AREA THE NEEDLE WAS REMOVED FROM (PULLED OUT OF). BLOOD DOES NOT NORMALLY COME OUT OF THIS PORT. IV NEEDED TO BE REMOVED AS WAS NOT FUNCTIONING AS INTENDED AND A NEW IV START WAS NEEDED. REGARDING PATIENT HARM/INJURY/NEGATIVE OUTCOMES, THE OUTCOME FOR THESE WAS THAT THE PATIENT NEEDED TO BE POKED AGAIN TO ESTABLISH IV ACCESS. THE IVS REMOVED WERE OTHERWISE WORKING AND SUCCESSFUL. FOR THE 18G IVS THAT LEAKED AFTER ACCESSING, THE CLINICIAN HAD TO CLEAN BLOOD OFF THE PATIENT THAT LEAKED CAUSING A LESS THAN SATISFACTORY PATIENT EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511970 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4232063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown