BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 7263508 · Received February 12, 2018

    Report

    Report Number
    1710034-2018-00042
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 30, 2018
    Report Date
    March 1, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835370
    PMA / PMN Number
    K115443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MDR LEVEL B INVESTIGATION: DHR REVIEW - ALL CHALLENGES AND INSPECTIONS RELATING TO THE DEFECT WERE CONDUCTED SUCCESSFULLY AND NO ISSUES WERE IDENTIFIED. QN REVIEW - NO QUALITY NOTIFICATIONS WERE INITIATED FOR THE COMPLAINT DEFECT. EURA REVIEW - THE CAUSE OF THE DEFECT IS MISALIGNMENT OF THE CANNULA INSERTION PROCESS. ACR 13-3300-755 WAS IMPLEMENTED WHICH HAS MITIGATED THE OCCURRENCE OF THE DEFECT. SAMPLE ANALYSIS - NO SAMPLES RETURNED. THE DEFECT WAS NOT CONFIRMED THROUGH THE INVESTIGATION. INVESTIGATION CONCLUSION: THE CAUSE WAS NOT IDENTIFIED DURING THE INVESTIGATION. RATIONALE: ACR 13-3300-755 WAS RECENTLY COMPLETED TO MITIGATE THE OCCURRENCE OF LEAKAGE AT THE SEPTUM.

    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.

    Additional Manufacturer Narrative · 1

    PMA/510K#: HAS BEEN CORRECTED TO K115443.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM AFTER INSERTION BLOOD WAS LEAKING FROM SELF-SEALING SEPTUM. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106013 "BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5072811 30382903835370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other