BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT

    MDR report key: 7974521 · Received October 17, 2018

    Report

    Report Number
    1710034-2018-00738
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 21, 2018
    Report Date
    December 10, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K161777
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 3 NEXIVA 20GA UNITS WITHIN SEALED PACKAGES FROM LOT NUMBER 8123501. ALL COMPONENTS WERE INTACT. THE LOT NUMBER WAS BUILT/PACKAGE ON NFA LINE 1 FROM (B)(6) 2018 THROUGH (B)(6) 2018 FOR THE AMOUNT OF (B)(6). 5 NON-RELATED TD¿S WERE IN PLACE DURING PRODUCTION. 2 NON-RELATED QN¿S WERE INITIATED AND DISPOSITION, ROOT CAUSE AND CORRECTIVE ACTIONS WERE APPLIED AS PER QUALITY CONTROL PLAN.ALL OTHER CHALLENGES, SET UP AND IN-PROCESS SAMPLES WERE PERFORMED AND ALL PASSED PER SPECIFICATIONS. VISUAL/MICROSCOPIC EVALUATION: NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON THE CATHETER OR THE EXTENSION TUBINGS. WATER-LEAK TEST: THE TEST WAS PERFORMED AND NO LEAKAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE UNITS RECEIVED. NO PHYSICAL-MECHANICAL DAMAGE OF MANUFACTURING RELATED DEFECTS WERE FOUND ON ANY OF THE REPRESENTATIVE UNITS RECEIVED. THE WATER-LEAK TEST PASSED AND NO LEAKAGE WAS OBSERVED. THE ACTUAL UNIT WHERE THE FAILURE OCCURRED WAS NOT RETURNED FOR EVALUATION. THE CANNULA OF THE NEXIVA DEVICE IS DESIGNED TO HAVE A HOLE, REFERRED TO AS A NOTCH, APPROXIMATELY 0.9 CM FROM THE TIP OF THE CANNULA INSERTION POINT THAT ALLOWS FOR BLOOD TO FLOW INTO THE SPACE BETWEEN THE CANNULA AND CATHETER (REFERENCE DRAWING (B)(4). THIS DESIGN FEATURE IS CALLED INSTAFLASH AND ALLOWS THE CLINICIAN TO VISUALIZE A SUCCESSFUL INSERTION INTO THE PATIENT¿S VASCULATURE. IT IS VERY IMPROBABLE THAT THE DESCRIBED DAMAGE (HOLE IN THE SIDE OF THE CANNULA) COULD BE PRODUCED BY THE MANUFACTURING PROCESS, AS THE CANNULA WOULD EITHER BE DESTROYED AND NOT ASSEMBLED INTO A FULL DEVICE, OR THE NEEDLE COVER AND/OR CATHETER TUBING WOULD HAVE SUSTAINED OBVIOUS DAMAGE. NO OTHER DAMAGE TO THE DEVICE WAS REPORTED. EURA (END USER RISK ANALYSIS) REVIEW IDENTIFIES CLINICIAN DISSATISFACTION AS HAVING NEGLIGIBLE SEVERITY OF S1. CLINICIAN DISSATISFACTION IS ACCEPTABLE AT ALL OCCURRENCE RATES. THERE IS NO RISK TO THE END USER. OCCURRENCE RATE OF THIS DEFECT FOR THIS BATCH IS REMOTE. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA CLOSED IV CATHETER SYSTEM WITH DUAL PORT HAD A DEFECTIVE CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 WITH DUAL PORT HAD A DEFECTIVE CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817136 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH DUAL PORT INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8123501 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other