BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ VENFLON IV CANNULA

    MDR report key: 8860546 · Received August 5, 2019

    Report

    Report Number
    2243072-2019-01605
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 17, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿TIP DAMAGE / PEEL BACK¿ WITH LOT NUMBER 9081823 REGARDING ITEM # 391592 THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. THE MANUFACTURING TEAM INSPECTED VARIOUS PRODUCT CHARACTERISTICS SUCH AS BEVEL ANGLE, PTFE TUBE THICKNESS, CANNULA OUTER DIAMETER FROM THE CURRENT RUNNING PRODUCTION LOTS. THE TEST RESULTS SHOWED THAT ALL THESE CHARACTERISTICS CONFIRMED TO THE PRODUCT DRAWING SPECIFICATIONS AND THEREFORE NO ROOT CAUSE COULD BE DETERMINED. HOWEVER, THE TEAM WILL CONTINUE TO MONITOR AND ANALYZE THESE CHARACTERISTICS, WHICH CAN POTENTIALLY CAUSE ¿PEEL BACK EFFECT¿. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ VENFLON IV CANNULA CATHETER TIP WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER USING VENFLON SINCE FIVE YEARS, THEY ARE NOT COMFORTABLE WITH RECENTLY SUPPLIED VENFLON I. AT THE TIME OF INSERTION FEELING DIFFICULTY WITH VENFLON I AS THERE IS TIP DAMAGE / PEEL BACK HAPPENING, AS PER SENIOR NURSE EXPERIENCE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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¿ VENFLON IV CANNULA CATHETER TIP WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER USING VENFLON SINCE FIVE YEARS, THEY ARE NOT COMFORTABLE WITH RECENTLY SUPPLIED VENFLON I. AT THE TIME OF INSERTION FEELING DIFFICULTY WITH VENFLON I AS THERE IS TIP DAMAGE / PEEL BACK HAPPENING, AS PER SENIOR NURSE EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656600 BD¿ VENFLON IV CANNULA CATHETER FOZ BECTON DICKINSON 9081823

    Patients

    Seq Age Sex Outcome Treatment
    1 Other