BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 19367190 · Received May 21, 2024

    Report

    Report Number
    1710034-2024-00462
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 16, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835126
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF A DAMAGED VENT PLUG WAS CONFIRMED FROM THE FOUR PHOTOGRAPHS AND THIRTEEN 22GA NEXIVA UNITS FROM LOT #3180979 THAT WERE PROVIDED FOR INVESTIGATION. ONE NEXIVA UNIT WAS RECEIVED WITHOUT THE VENT PLUG. THE PHYSICAL SAMPLES AND PHOTOS SHOWED WHAT APPEARED TO BE A BURR, FLASH, OR DEFORMATION AT THE TIP OF THE VENT PLUG. DURING MANUFACTURING, DAMAGE TO THE TIP OF THE VENT PLUG MAY OCCUR DUE TO INCORRECT PROCESSING PARAMETERS AND MISALIGNMENT BETWEEN THE VENT PLUG AND LUER ADAPTER. THE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. THE VENT PLUG INSERTION SPEED WAS RESET TO THE CORRECT PARAMETER AND LOCKED TO PREVENT FUTURE CHANGES TO THE SPEED. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS AND CURRENTLY DO NOT INDICATE THE NEED FOR A FORMAL CORRECTIVE ACTION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Additional Manufacturer Narrative · 0

    E. ADDRESS CHARACTER LIMIT IS EXCEEDED: (B)(6). E. FACILITY NAME CHARACTER LIMIT IS EXCEEDED: (B)(6) HOSPITAL. 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 FOREIGN MATTER ON PLUG- PLASTIC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN I OPENED THE PACKAGE, I FOUND THAT THERE WERE BURRS ON THE END OF THE CAP, THE SURFACE OF THE END CAP WAS UNEVEN, AND THE GEL WAS STUCK TO THE END OF THE CAP. I NEED TO CLAIM COMPENSATION, A COMPLAINT REPLY LETTER, AND A COMPLAINT RECEIPT LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500955 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3180979 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown