BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12776490 · Received November 9, 2021

    Report

    Report Number
    1710034-2021-00964
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 11, 2021
    Report Date
    November 12, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835394
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1071078, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2021-03-12. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A PLACEHOLDER BASED ON THE REPORTED PHONE AREA CODE. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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 1 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM FROM LOT 1071078, AND 1 CATHETER FROM AN UNSPECIFIED LOT LEAKED FROM THE SEPTUM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THERE WERE TWO DIFFERENT INSTANCES WHERE THE NEEDLE STARTED LEAKING FROM THE SEPTUM. BOTH INSTANCES THE NEEDLE NEEDED TO BE REPLACED. CUSTOMER ONLY HAD MATERIAL AND LOT NUMBER AND DATE FOR ONE OCCURRENCE- (B)(6) 2021. THE OTHER OCCURRENCE IS UNKNOWN DATE AND LOT NUMBER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM FROM LOT 1071078, AND 1 CATHETER FROM AN UNSPECIFIED LOT LEAKED FROM THE SEPTUM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THERE WERE TWO DIFFERENT INSTANCES WHERE THE NEEDLE STARTED LEAKING FROM THE SEPTUM. BOTH INSTANCES THE NEEDLE NEEDED TO BE REPLACED. CUSTOMER ONLY HAD MATERIAL AND LOT NUMBER AND DATE FOR ONE OCCURRENCE: (B)(6) 2021. THE OTHER OCCURRENCE IS UNKNOWN DATE AND LOT NUMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676756 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383539 SEE SECTION H.10. 30382903835394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown