BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9695677 · Received February 11, 2020

    Report

    Report Number
    1710034-2020-00073
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    January 22, 2020
    Report Date
    April 1, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835127
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD RECEIVED ONE USED NEXIVA 22GA UNIT IN AN OPENED PACKAGE FROM MATERIAL NUMBER 383512, LOT NUMBER 9260323. FIVE DISPENSERS WITH 20 UNITS/DISPENSER FOR A TOTAL OF 100 UNUSED NEXIVA 22GA UNITS IN SEALED PACKAGES FROM MATERIAL NUMBER 383512, LOT NUMBER 9260323 WERE ALSO RECEIVED. IN ADDITION, THREE PHOTOGRAPHS WERE SUBMITTED WHICH DID NOT DISPLAY ENOUGH EVIDENCE TO IDENTIFY OR CONFIRM THE REPORTED ISSUE. FIRST, A VISUAL/MICROSCOPIC EVALUATION WAS PERFORMED ON THE RETURNED USED UNIT. THERE WAS NO DAMAGE TO THE STRAIGHT ADAPTER OR THE VENT PLUG. THE VENT PLUG WAS REMOVED BY HAND IN WHICH THE VENT PLUG WAS EASILY REMOVED. A RANDOM SAMPLING OF 81 UNITS WERE TESTED FOR THE FLOW CONTROL PLUG REMOVAL TORQUE. 43 OUT OF THE 81 UNITS TESTED AT A GREATER TORQUE THAN SPECIFICATIONS STATE. THE REPORTED ISSUE OF THE VENT PLUG BEING DIFFICULT TO REMOVE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. 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 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM PLUG WAS HARD TO REMOVE. THIS OCCURRED ON 5 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PUNCTURED, HCP TRIED TO REMOVE THE PLUG HOWEVER IT WAS VERY HARD TO REMOVE.

    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 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM PLUG WAS HARD TO REMOVE. THIS OCCURRED ON 5 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PUNCTURED, HCP TRIED TO REMOVE THE PLUG HOWEVER IT WAS VERY HARD TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160229 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383512 9260323 30382903835127

    Patients

    Seq Age Sex Outcome Treatment
    1 Other