BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 19326094 · Received May 15, 2024

    Report

    Report Number
    1710034-2024-00445
    Event Type
    Malfunction
    Date Received
    May 15, 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

    ADDRESS CHARACTER LIMIT IS EXCEEDED: (B)(6). FACILITY NAME CHARACTER LIMIT IS EXCEEDED:(B)(6) MEDICAL UNIVERSITY (B)(6) HOSPITAL (HUSHAN ROAD CAMPUS). A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE COMPLAINT OF MATERIAL STUCK TO THE END OF THE CAP WAS CONFIRMED. NO GEL WAS OBSERVED FROM THE FOUR PHOTOGRAPHS OR THIRTEEN 22GA NEXIVA UNITS FROM LOT #3180979 THAT WERE PROVIDED FOR INVESTIGATION; HOWEVER, THE OBSERVED DAMAGE COULD BE ASSOCIATED WITH THE DAMAGED VENT PLUGS. THE PHYSICAL SAMPLES AND PHOTOS SHOWED WHAT APPEARED TO BE A BURR, FLASH, OR DEFORMATION AT THE TIP OF THE VENT PLUG. ONE PHOTO SHOWED MATERIAL INSIDE THE BLUE ADAPTER, WHICH MAY HAVE BEEN GEL OR A PIECE OF MATERIAL FROM THE VENT PLUG. THE PHYSICAL SAMPLES DID NOT EXHIBIT THIS DAMAGE; THEREFORE, THE ROOT CAUSE, COMPOSITION, AND SOURCE OF THE MATERIAL COULD NOT BE DETERMINED. GEL IS NOT USED DURING ASSEMBLY OF THIS COMPONENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT FOREIGN MATTER IN HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN I OPENED THE PACKAGE, I FOUND THAT GEL WAS STUCK TO THE END OF THE CAP. (A WHOLE PIECE OF GEL APPEARS IN THE END INTERFACE OF THE EXTENSION TUBE.)

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454707 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