BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9535817 · Received December 31, 2019

    Report

    Report Number
    1710034-2019-01372
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 13, 2019
    Report Date
    February 4, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835325
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED THREE REPRESENTATIVE UNITS FROM CATALOG NUMBER 383532, LOT NUMBER 9050711. IN ADDITION, TWO PHOTOGRAPHS WERE ALSO SUBMITTED WHICH DISPLAYED THE LABEL INFORMATION. THROUGH THE VISUAL EXAMINATION, THE UNITS WERE INSPECTED FOR ANY CUTS/SLIT, DAMAGE, OR KINKS IN THE DEVICE THAT MAY CAUSE LEAKAGE. A LEAK TEST WAS PERFORMED WHERE LEAKAGE WAS NOT OBSERVED. THE RETURNED REPRESENTATIVE UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED REPORTED. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. 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 H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM CANNULA TUBING DURING A BLOOD TRANSFUSION ONCE IT HAD STARTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE INCIDENT HAPPENED ON (B)(6)2019 DURING A BLOOD TRANSFUSION ON A PATIENT, A MEMBER OF STAFF NOTICED THAT THERE APPEARED TO BE BLOOD COMING FROM THE CANNULA TUBING ONCE THE TRANSFUSION HAD COMMENCED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM CANNULA TUBING DURING A BLOOD TRANSFUSION ONCE IT HAD STARTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE INCIDENT HAPPENED ON FRIDAY (B)(6) 2019 DURING A BLOOD TRANSFUSION ON A PATIENT, A MEMBER OF STAFF NOTICED THAT THERE APPEARED TO BE BLOOD COMING FROM THE CANNULA TUBING ONCE THE TRANSFUSION HAD COMMENCED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331575 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383532 9050711 30382903835325

    Patients

    Seq Age Sex Outcome Treatment
    1 Other