BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 11805841 · Received May 11, 2021

    Report

    Report Number
    8041187-2021-00395
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE FIRST TWO PHOTOS SHOW THE SHELF CARTON OF BATCH 0171276 AND THE THIRD PHOTO SHOWS THE TOP WEB OF BATCH 0171276. AS NO SAMPLE OR PHOTO OF THE DEFECT PROVIDED TO BD FOR EVALUATION, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BD IS AWARE OF THIS ISSUE AND IS IN THE PROCESS OF IMPLEMENTING CORRECTIVE ACTIONS TO IMPROVE THE CUSTOMER AND PATIENT EXPERIENCE. CAPA 1379444 HAS BEEN INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACTUALLY THEY WORK WITH PRODUCTS MADE IN 2019. PRODUCTS MADE IN 2020 CANNOT BE USED BECAUSE THE CANNULAS LEAKING THE TIME IN USE, AND IN THIS CASE AN EMPLOYEE HAS TO ESCORT THE WHOLE USING TIME OF THE CANNULA.". "THEY GOT A VERBAL INFORMATION THAT THE BATCHES FROM 2020 WERE PRODUCED WITH ANOTHER STERILIZATION METHOD, AND SINCE THEN THEY HAVE LEAKING CANNULAS. THIS TOPIC SEEMS TO BE DISCUSSED FOR A LONG TIME INSIDE THE UNIVERSITÄTSKLINIKUM."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. 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 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACTUALLY THEY WORK WITH PRODUCTS MADE IN 2019. PRODUCTS MADE IN 2020 CANNOT BE USED BECAUSE THE CANNULAS LEAKING THE TIME IN USE, AND IN THIS CASE AN EMPLOYEE HAS TO ESCORT THE WHOLE USING TIME OF THE CANNULA." "THEY GOT A VERBAL INFORMATION THAT THE BATCHES FROM 2020 WERE PRODUCED WITH ANOTHER STERILIZATION METHOD, AND SINCE THEN THEY HAVE LEAKING CANNULAS. THIS TOPIC SEEMS TO BE DISCUSSED FOR A LONG TIME INSIDE THE (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702888 BD VENFLON PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0171276

    Patients

    Seq Age Sex Outcome Treatment
    1