BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN

    MDR report key: 9746406 · Received February 24, 2020

    Report

    Report Number
    1710034-2020-00105
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    February 3, 2020
    Report Date
    April 8, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835362
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPHS WHICH DISPLAYED AN OPENED PACKAGE WITH A 20GA BD NEXIVA IV CATHETER SYSTEM DUAL PORT UNIT. THE UNIT CONSISTED OF THE DUAL PORT ADAPTER THAT HAS A PORTION OF EXTENSION LINE INTACT WITH THE PINCH CLAMP ATTACHED ON THE LINE. THERE IS ALSO A Q-SYTE ATTACHED TO THE LUER OF ONE PORT AND A VENT PLUG ATTACHED TO THE SECOND PORT. AN ADDITIONAL Q-SYTE WITH DUST CAP IS ALSO INSIDE THE PACKAGE. THE REPORTED ISSUE WAS CONFIRMED. THE PHOTO REVEALS THAT A CUT OR BREAK TO THE EXTENSION TUBING MOST LIKELY OCCURRED, THIS IS BASED ON THE SEEN LENGTH OF THE TUBING IN THE PHOTO AND CANNOT BE CONFIRMED WITHOUT THE ACTUAL UNIT. AN INVESTIGATION WITH THE ACTUAL UNIT MAY PROVIDE REASON AS TO WHY THIS DEFECT OCCURRED. THE PHOTOGRAPH DID NOT PROVIDE SUFFICIENT EVIDENCE TO DETERMINE A ROOT CAUSE. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9241111. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN WAS NOT IN THE UNOPENED PACKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IT WAS REPORTED THE EXTENSION SET WAS MISSING FROM PACKAGE. UNOPENED PACKAGE IS MISSING THE EXTENSION SET. PRODUCT WAS UNABLE TO BE USED AS NOT COMPLETE."

    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 WAS REPORTED THAT THE BD BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN WAS NOT IN THE UNOPENED PACKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IT WAS REPORTED THE EXTENSION SET WAS MISSING FROM PACKAGE. UNOPENED PACKAGE IS MISSING THE EXTENSION SET (AS PER PICTURE). PRODUCT WAS UNABLE TO BE USED AS NOT COMPLETE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211755 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM - DUAL PORT 20 GA 1.00 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9241111 00382903835362

    Patients

    Seq Age Sex Outcome Treatment
    1 Other