BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY

    MDR report key: 17656609 · Received August 30, 2023

    Report

    Report Number
    2243072-2023-01538
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A PHOTO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A VENFLON I 20G FROM LOT NUMBER 13033360 REGARDING MATERIAL NUMBER 391591 WITH THE REPORTED ISSUE OF ¿CATHETER DEFECTIVE / DAMAGED¿. BASED ON THE PHOTOGRAPH DEFECT CANNOT BE CONFIRMED. THE DEVICE HISTORY REVIEW OF LOT NUMBER 3033360 WITH MATERIAL NUMBER 391591 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON 25 RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR CATHETER DEFECTIVE / DAMAGED AND NO DEFECT WAS FOUND IN THE RETENTION SAMPLES. THE EXACT ROOT CAUSE CAN ONLY BE DETERMINED IF WE RECEIVE THE ORIGINAL SAMPLE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP OF THE BD VENFLON¿ PRO SAFETY WAS DAMAGED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: TIP FOR VENFLON I 22G WAS DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TIP OF THE BD VENFLON¿ PRO SAFETY WAS DAMAGED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: TIP FOR VENFLON I 22G WAS DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183079 BD VENFLON¿ PRO SAFETY INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3033360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown