BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON 2 BL 22GA IV CANNULA

    MDR report key: 11072420 · Received December 24, 2020

    Report

    Report Number
    2243072-2020-02166
    Event Type
    Malfunction
    Date Received
    December 24, 2020
    Date of Event
    November 27, 2020
    Report Date
    January 6, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE MDR 2243072-2020-02166 IS A DUPLICATE OF 2243072-2020-02161 THIS SUPPLEMENTAL IS TO CANCEL MDR 2243072-2020-02166.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VENFLON 2 BL 22GA IV CANNULA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CANNULA INSERTED SUCCESSFULLY FIRST PASS. INTRODUCER NEEDLE REMOVED AND END CAP ATTACHED. WHILST SECURING TO PATIENT BLOOD NOTED AROUND HUB. CANNULA INSPECTED AND ON REMOVING CAP FROM TOP-PORT BLOOD NOTED TO BE FREELY FLOWING, SO CAP RECLOSED AND CANNULA REMOVED. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NONE BAR NEED FOR REPEAT CANNULATION. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER) CANNULA REMOVED AND NEW CANNULA (DIFFERENT MODEL) SITED WITH NO ISSUES."

    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. (B)(4). OEM MANUFACTURE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT VENFLON 2 BL 22GA IV CANNULA LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CANNULA INSERTED SUCCESSFULLY FIRST PASS. INTRODUCER NEEDLE REMOVED AND END CAP ATTACHED. WHILST SECURING TO PATIENT BLOOD NOTED AROUND HUB. CANNULA INSPECTED AND ON REMOVING CAP FROM TOP-PORT BLOOD NOTED TO BE FREELY FLOWING, SO CAP RECLOSED AND CANNULA REMOVED. DETAILS OF INJURY (TO PATIENT, CARER OR HEALTHCARE PROFESSIONAL): NONE BAR NEED FOR REPEAT CANNULATION. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL, OR BY THE MANUFACTURER OR SUPPLIER) CANNULA REMOVED AND NEW CANNULA (DIFFERENT MODEL) SITED WITH NO ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1537021 VENFLON 2 BL 22GA IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 9235103

    Patients

    Seq Age Sex Outcome Treatment
    1