BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON 2 BL 22GA IV CANNULA

    MDR report key: 12170792 · Received July 14, 2021

    Report

    Report Number
    2243072-2021-01874
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 15, 2021
    Report Date
    June 29, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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. INVESTIGATION SUMMARY: SINCE NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿LEAKAGE IN THE INJECTION¿, WITH REPORTED LOT # 0182212 REGARDING ITEM # 391451, THE COMPLAINT COULD NOT BE CONFIRMED. THE DHR OF MATERIAL NUMBER 391451 AND LOT NUMBER 0182212 WAS CHECKED FOR ANY QUALITY NOTIFICATIONS, AND THERE WERE NO QUALITY NOTIFICATIONS RAISED ON THIS LOT. NO SAMPLES AND NO PHOTOGRAPHS RECEIVED FROM THE CUSTOMER. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MATERIAL CODE 391451 AND LOT NUMBER 0182212 FOR INVESTIGATING THE REPORTED DEFECT. THE TEN RETENTION SAMPLES OF 0182212 WERE CHECKED FOR LEAKAGE. NO RETENTION SAMPLE SHOWED ANY LEAKAGE. THE DEFECT COULD NOT BE CONFIRMED. INVESTIGATION CONCLUSION: 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE IS UNDETERMINED.

    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: PVK HAD A LEAKAGE IN THE INJEKTIONPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1067356 VENFLON 2 BL 22GA IV CANNULA CATHETER FOZ BECTON DICKINSON 0182212

    Patients

    Seq Age Sex Outcome Treatment
    1