BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON IV CANNULA 20G

    MDR report key: 17290151 · Received July 10, 2023

    Report

    Report Number
    2243072-2023-01190
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 17, 2023
    Report Date
    August 15, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903915927
    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

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿CATHETER TIP INTEGRITY¿ WITH LOT NUMBER 3093480 REGARDING MATERIAL NUMBER 391592, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE DEVICE HISTORY REVIEW (DHR) OF MATERIAL NUMBER 391592 WITH LOT NUMBER 3093480 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 SAMPLES FOR CATHETER TIP INTEGRITY. NO 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.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL. THIS SITE IS AN OEM MANUFACTURING SITE. 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. B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. 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 · 0

    IT WAS REPORTED WHILE USING BD VENFLON IV CANNULA 20G THE CATHETER TIP WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER SITE SHOWING SIGNS OF COMPLICATIONS AFTER 7-8HRS OF INSERTION IN MULTIPLE PATIENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VENFLON IV CANNULA 20G THE CATHETER TIP WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER SITE SHOWING SIGNS OF COMPLICATIONS AFTER 7-8HRS OF INSERTION IN MULTIPLE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196963 BD VENFLON IV CANNULA 20G INTERVASCULAR CATHETER FOZ BECTON DICKINSON 3093480 00382903915927

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown