BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENLON IV CANNULA

    MDR report key: 15620345 · Received October 17, 2022

    Report

    Report Number
    2243072-2022-01772
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    September 19, 2022
    Report Date
    October 10, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6), INDIA. THIS SITE IS NOT REGISTERED WITH THE FDA. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿CATHETER DAMAGE¿ WITH LOT NUMBER 2073113 REGARDING ITEM NUMBER 391592, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TWO RETENTION SAMPLES. THE INVESTIGATING TEAM HAS VISUALLY TESTED THE RETENTION SAMPLES FOR CATHETER DAMAGE AND NO CATHETER DAMAGE WAS FOUND ON THE TWO RETENTION SAMPLES. SINCE THERE ARE NO SAMPLES AND NO PHOTOGRAPH, THE DEFECT COULD NOT BE CONFIRMED. TO CONFIRM THE DEFECT AND INVESTIGATE THE ROOT CAUSE THE ORIGINAL SAMPLE WILL BE NEEDED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 100 BD VENLON IV CANNULAS EXPERIENCED CATHETER SPLITTING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER IS TEARING FROM TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370643 BD VENLON IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 2073113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown