BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DUAL PORT WITH CAP 20GA 1.00IN (1.1 MM X 25 MM)

    MDR report key: 8803108 · Received July 18, 2019

    Report

    Report Number
    1710034-2019-00781
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 2, 2019
    Report Date
    September 13, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 2 NEXIVA 20 GAUGE UNITS FROM LOT 8142579 FOR EVALUATION. ONE UNIT WAS RECEIVED INSIDE ITS ORIGINAL SEALED PACKAGING AND THE SECOND UNIT WAS RECEIVED IN A MISCELLANEOUS PACKAGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED BOTH UNITS AND OBSERVED TRACES OF BLOOD IN THE SECOND UNIT AND A CRACK ALONG THE LUER AND UP THE NOSE OF THE ADAPTER. THERE APPEARED TO BE NO PHYSICAL/MECHANICAL DAMAGE TO THE SEALED UNIT AND NO RESISTANCE WAS FELT OR CRACK WAS SEEN WHEN CONNECTING IT TO AN EXTENSION SET. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. HOWEVER, SINCE THE UNIT WASN'T RECEIVED IN ITS ORIGINAL PACKAGING A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE DAMAGE CAME FROM THE MANUFACTURING PROCESS OR DURING USE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD NEXIVA DUAL PORT WITH CAP 20GA 1.00IN (1.1 MM X 25 MM) HAS BEEN FOUND WITH THE CATHETER CONNECTOR BREAKING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE NURSE WANTED TO CHANGE THE PERIPHERAL CATHETER KIT. BY CONNECTING THE EXTENDER TO THE CHANNEL PROVIDED FOR THIS PURPOSE, ONE OF THE BRANCHES OF THE Y SPLIT.

    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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD NEXIVA DUAL PORT WITH CAP 20GA 1.00IN (1.1 MM X 25 MM) HAS BEEN FOUND WITH THE CATHETER CONNECTOR BREAKING DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE NURSE WANTED TO CHANGE THE PERIPHERAL CATHETER KIT. BY CONNECTING THE EXTENDER TO THE CHANNEL PROVIDED FOR THIS PURPOSE, ONE OF THE BRANCHES OF THE Y SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599454 BD NEXIVA DUAL PORT WITH CAP 20GA 1.00IN (1.1 MM X 25 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8142579

    Patients

    Seq Age Sex Outcome Treatment
    1 Other