BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 9162516 · Received October 7, 2019

    Report

    Report Number
    1710034-2019-01085
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    December 6, 2017
    Report Date
    November 12, 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

    INVESTIGATION: BD RECEIVED A 20 GAUGE NEXIVA UNIT WITH 2 ATTACHED Q-SYTE ASSEMBLIES 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 UNIT. THE EXTENSION TUBING WAS CLOGGED WITH A WHITE MEDICINAL SUBSTANCE PREVENTING A WATER/AIR LEAK TEST FROM BEING PERFORMED. THE Q-SYTE UNITS WERE INSPECTED AND TEARS WERE OBSERVED ON THE TOP AND BOTTOM SLIT OF THE SEPTUM DISK FOR THE FIRST UNIT AND ONLY ON THE TOP DISK OF THE SECOND. NO DAMAGE WAS OBSERVED TO THE COLUMN WALLS. A WATER/AIR LEAK TEST WAS PERFORMED ON BOTH UNITS IN THE ACTUATED AND UNACTUATED POSITIONS BUT NO LEAKAGE WAS OBSERVED. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO LEAKAGE WAS OBSERVED COMING FROM THE Q-SYTE CONNECTIONS A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NEXIVA DUAL PORT 20GA 1.25IN (1.1 MM X 32 MM) EXPERIENCED LEAKAGE AT THE SEPTUM AND EXTRAVASATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOTICED EXTRAVASATION AT THE TIME OF THE CONTRAST INJECTION, WE PLACED ANOTHER KEY AND WERE ABLE TO PROCEED WITH THE EXAMINATION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NEXIVA DUAL PORT 20GA 1.25IN (1.1 MM X 32 MM) EXPERIENCED LEAKAGE AT THE SEPTUM AND EXTRAVASATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NOTICED EXTRAVASATION AT THE TIME OF THE CONTRAST INJECTION, WE PLACED ANOTHER KEY AND WERE ABLE TO PROCEED WITH THE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954622 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