BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON I 20GA 1.0 MM X 32MM

    MDR report key: 12363500 · Received August 24, 2021

    Report

    Report Number
    2243072-2021-02169
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    July 23, 2021
    Report Date
    August 25, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOGRAPHS RECEIVED FROM THE CUSTOMER. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MATERIAL CODE 391592 AND LOT NUMBER 1120010 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION TEAM HAS CARRIED OUT THE SIMULATION OF THE COMPLAINT ON THE 10 RETENTION SAMPLES OF PRODUCT MATERIAL CODE 391592 AND LOT NUMBER 1120010. BASED ON THE SIMULATION CARRIED OUT ON THE VENFLON I RETENTION SAMPLE TO CONFIRM THE DEFECT FOREIGN MATTER(RUST) IT WAS FOUND THAT THE RUST COULD BE THE EYE MADE ON VENFLON I; VENFLON I HAS A EYE MADE ON THE NEEDLE A FEATURE TO HELP THE CARE GIVER TO KNOW IF HE HAS REACHED THE VEIN. THE DEFECT COULD NOT BE CONFIRMED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENFLON I 20GA 1.0 MM X 32MM NEEDLE WAS RUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF THE CANNULA NEEDLE WAS FOUND RUSTED."

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENFLON I 20 GA 1.0 MM X 32 MM NEEDLE WAS RUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF THE CANNULA NEEDLE WAS FOUND RUSTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254977 VENFLON I 20GA 1.0 MM X 32MM INTRAVASCULAR CATHETER FOZ 1120010

    Patients

    Seq Age Sex Outcome Treatment
    1