BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15965532 · Received December 12, 2022

    Report

    Report Number
    1710034-2022-00795
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 21, 2022
    Report Date
    January 30, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835301
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH THREE PHOTOS OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 2182100, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS AND OBSERVED THAT THE FLANGES OF THE BOTTOM PORTION OF THE PACKAGING APPEARED CURLED AND THE RIGHT TRAY WAS WARPED. THE RIGID PACKAGING MATERIAL WAS DEFORMED AND APPEARED TO HAVE A REDUCTION IN THE WIDTH OF THE SEAL IN ONE ARE OF THE STERILE BARRIER. THEREFORE, BASED OFF THE PROVIDED PHOTOS THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR INSPECTION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE SEAL WAS COMPROMISED. THIS OCCURRED 72 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND 72 DAMAGE PACKAGES OF NEXIVA DUAL PORT 0.56" SO CUSTOMERS CONCERNED ABOUT STERILITY AND CONTAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ CLOSED IV CATHETER SYSTEM THE SEAL WAS COMPROMISED. THIS OCCURRED 72 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOUND 72 DAMAGE PACKAGES OF NEXIVA DUAL PORT 0.56" SO CUSTOMERS CONCERNED ABOUT STERILITY AND CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419763 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383530 2182100 30382903835301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown