BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON IV CANNULA 20G

    MDR report key: 17389954 · Received July 25, 2023

    Report

    Report Number
    2243072-2023-01306
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    July 1, 2023
    Report Date
    August 7, 2023
    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 BAWAL, INDIA. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A PHOTO WAS RETURNED FOR THE REPORTED ISSUE OF ¿NEEDLE PENETRATION DIFFICULT / PAINFUL NEEDLE DISENGAGEMENT DIFFICULT¿ WITH LOT NUMBER 3041281 REGARDING MATERIAL NUMBER 391593. IN THE PHOTO, THE PACKAGING CAN BE SEEN. RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE DEVICE HISTORY REVIEW (DHR) OF MATERIAL NUMBER 391593 WITH LOT NUMBER 3041281 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NUMBER FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON A RETENTION SAMPLE WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLE FOR NEEDLE PENETRATION DIFFICULT / PAINFUL NEEDLE DISENGAGEMENT DIFFICULT AND NO SUCH TYPE OF DEFECT WAS FOUND IN THE RETENTION SAMPLE. THE EXACT ROOT CAUSE CAN ONLY BE DETERMINED IF WE RECEIVE THE ORIGINAL SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT CANNOT BE INVESTIGATED FURTHER. 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. SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON IV CANNULA 20G NEEDLE WOULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL IS USING VENFLON I FOR THE LAST MANY YEARS WHEN I VISITED ON (B)(6) 2023 DR (ICU INTENSIVIST) COMPLAINED THAT ON DUTY DOCTOR DURING IV CANNULATION FELT VERY RESISTANCE WHILE REMOVING THE STYLET FROM THE CATHETER DUE TO WHICH THEY ARE FACING DIFFICULTY TO PERFORM CANNULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON IV CANNULA 20G NEEDLE WOULD NOT DISENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL IS USING VENFLON I FOR THE LAST MANY YEARS WHEN I VISITED ON (B)(6) 2023 DR (ICU INTENSIVIST) COMPLAINED THAT ON DUTY DOCTOR DURING IV CANNULATION FELT VERY RESISTANCE WHILE REMOVING THE STYLET FROM THE CATHETER DUE TO WHICH THEY ARE FACING DIFFICULTY TO PERFORM CANNULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2338968 BD VENFLON IV CANNULA 20G INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3117006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown