BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 20 GA X 1-3/4 IN SINGLE PORT

    MDR report key: 18663804 · Received February 7, 2024

    Report

    Report Number
    1710034-2024-00089
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 19, 2024
    Report Date
    July 16, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835189
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS FOR EVALUATION. THE FIRST PHOTOGRAPH SHOWED THE TOP WEB OF TWO UNOPENED UNIT PACKAGES FROM THE IMPLICATED 20G X 1.75¿ NEXIVA CLOSED IV CATHETER SYSTEM. THE LABELING INFORMATION WAS MISSING FROM THE TOP WEB ON THESE TWO PACKAGES. THE SECOND PHOTOGRAPH SHOWED AN UNAFFECTED PACKAGE FROM A 20G X 1.75¿ NEXIVA CLOSED IV CATHETER SYSTEM AND THE DISPENSER BOX. THE UNAFFECTED TOP WEB CONTAINED THE RELEVANT PRINTED PRODUCT INFORMATION PER DESIGN. THE TOP WEB AND DISPENSER BOX WERE LABELED WITH REF: (B)(4) AND LOT: 3180984. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THE REPORTED PRODUCTION BATCHES. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY. CUSTOMER ADDRESS ADDED TO E TAB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO BD NEXIVA 20 GA X 1-3/4 IN SINGLE PORTS WERE MISSING THE LABEL CONTENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO NEXIVA CATHETER PACKAGES DID NOT HAVE ANYTHING PRINTED ON THE FRONT WHEN RECEIVED BY CUSTOMER. THE REMAINDER OF THE BOX WAS FINE."

    Description of Event or Problem · 0

    NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364842 BD NEXIVA 20 GA X 1-3/4 IN SINGLE PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3180984 30382903835189

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown