BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT 20GA 1.00IN (1.1 MM X 25 MM)

    MDR report key: 9198103 · Received October 16, 2019

    Report

    Report Number
    1710034-2019-01116
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    October 3, 2019
    Report Date
    November 18, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835165
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED 58 NEXIVA CLOSED IV CATHETER SINGLE PORT 20 GAUGE UNITS FROM LOT 8214832 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 UNITS AND OBSERVED NO PHYSICAL/MECHANICAL DAMAGE. NEXT, THE ENGINEER ATTEMPTED TO SEPARATE THE EXTENSION LINE FROM THE WINGED INSERTER AND NO SEPARATION WAS OBSERVED. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE FOUND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NEXIVA SINGLE PORT 20GA 1.00IN (1.1 MM X 25 MM) EXPERIENCED TUBING SEPARATED FROM ADAPTOR/LUER CONNECTOR WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383516 BATCH NO: 9870371. TUBE IS SEPARATING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 SINGLE PORT 20GA 1.00IN (1.1 MM X 25 MM) EXPERIENCED TUBING SEPARATED FROM ADAPTOR/LUER CONNECTOR WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383516. BATCH NO: 9870371. TUBE IS SEPARATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993144 BD NEXIVA SINGLE PORT 20GA 1.00IN (1.1 MM X 25 MM) INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8214832 30382903835165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other