BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 10476341 · Received September 1, 2020

    Report

    Report Number
    1710034-2020-00548
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 11, 2020
    Report Date
    October 23, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO NEXIVA 20GA UNITS FROM MATERIAL 383647, LOT NUMBER 8142579. ONE UNIT WAS USED AND IN AN OPENED PACKAGE AND ONE UNUSED REPRESENTATIVE UNIT IN A SEALED PACKAGE. IN ADDITION, FOUR PHOTOGRAPHS WERE RECEIVED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED USED UNIT. THROUGH THE VISUAL/MICROSCOPIC EVALUATION ON THE RETURNED USED SAMPLE, A CHARACTERISTIC V SHAPE OF A SPEAR THROUGH AND SLIT/CUT IN THE CATHETER TUBING WAS OBSERVED ABOVE THE NOSE OF THE ADAPTER. THE TUBING BETWEEN THE V SHAPE AND SLIT/CUT WAS COLLAPSED. THE COLLAPSED AREA WAS FROM THE NEEDLE WHICH HAD SPEARED OUT THROUGH THE TUBING AND BACK INTO THE TUBING. THE REPORTED ISSUE WAS CONFIRMED AS THE NEEDLE WENT THROUGH THE CATHETER. A VISUAL/MICROSCOPIC EVALUATION WAS THEN PERFORMED ON THE RETURNED UNUSED SAMPLE. THERE WERE NO SIGNS OF HOLES, SPLITS, OR NEEDLE THROUGH TUBING WALL FOUND IN THE TUBING. THE EVALUATION OF THE USED UNIT WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. SPEARS THROUGH CAN OCCUR AT THE TUBE FLARE STATION WHEN THE CATHETER IS SET TO THE WEDGE FROM THE MANDREL HITTING THE CATHETER. IT COULD ALSO OCCUR AT THE LOAD ADAPTER AND SEAT SEPTUM STATION FROM MACHINE ALIGNMENT ISSUES. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HUB WAS BROKEN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEALED CANULA BD NEXIVA VF GAUGE 20, WAS USED FOR IV CANNULATION. AFTER INSERTION, IV SITE WAS BLEEDING AND NOT ABLE TO EXTRACT BLOOD FOR BLOOD TEST. CANNULA REMOVED IMMEDIATELY AND NOTED THAT THE PLASTIC HUB WAS BROKEN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM HUB WAS BROKEN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEALED CANULA BD NEXIVA VF GAUGE 20, WAS USED FOR IV CANNULATION. AFTER INSERTION, IV SITE WAS BLEEDING AND NOT ABLE TO EXTRACT BLOOD FOR BLOOD TEST. CANNULA REMOVED IMMEDIATELY AND NOTED THAT THE PLASTIC HUB WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945130 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8142579

    Patients

    Seq Age Sex Outcome Treatment
    1 Other