BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DUAL PORT 20GA 1.25IN (1.1 MM X 32 MM)

    MDR report key: 9162618 · Received October 7, 2019

    Report

    Report Number
    1710034-2019-01086
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    January 15, 2018
    Report Date
    November 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835370
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A 20 GAUGE NEXIVA UNIT WITH A Y-EXTENSION SET AND 2 Q-SYTE UNITS FROM LOT 5183657 FOR EVALUATION. 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 THE RETURNED UNIT AND OBSERVED NO PHYSICAL/MECHANICAL DAMAGE TO THE NEXIVA OR FIRST Q-SYTE UNIT. THE SECOND Q-SYTE UNIT HAD TEARS ON THE SLITS OF THE TOP AND BOTTOM OF THE SEPTUM DISKS. NEXT, A WATER/AIR LEAK TEST WAS PERFORMED AND NO LEAKAGE WAS OBSERVED COMING FROM ANY OF THE UNITS. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS OR LEAKAGE WAS FOUND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD NEXIVA DUAL PORT 20GA 1.25IN (1.1 MM X 32 MM) HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: LEAKING THROUGH THE PLUG.

    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 20GA 1.25IN (1.1 MM X 32 MM) HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: LEAKING THROUGH THE PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954723 BD NEXIVA DUAL PORT 20GA 1.25IN (1.1 MM X 32 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5183657 30382903835370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other