BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 11665768 · Received April 14, 2021

    Report

    Report Number
    8041187-2021-00279
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    January 13, 2021
    Report Date
    April 20, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY . THERE WAS NO SAMPLE OR PHOTO PROVIDED TO BD FOR EVALUATION. THEREFORE, 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. THOUGH THE INCIDENT COULD NOT BE CONFIRMED BASED ON THIS COMPLAINT, BD IS AWARE OF THIS ISSUE AND IS IN THE PROCESS OF IMPLEMENTING CORRECTIVE ACTIONS TO IMPROVE THE CUSTOMER AND PATIENT EXPERIENCE. CAPA#1379444 WAS INITIATED TO ADDRESS THE ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER EACH FROM LOTS 0022739, 0206932, AND 0022740 LEAKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE BEEN ADVISED BY A CUSTOMER THAT THEY HAVE HAD A NUMBER OF ¿LEAKAGE¿ ISSUES ACROSS THE VENFLON PRO SAFETY RANGE."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0022739, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0206932, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, . DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0022740, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. 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 1 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER EACH FROM LOTS 0022739, 0206932, AND 0022740 LEAKED DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE BEEN ADVISED BY A CUSTOMER THAT THEY HAVE HAD A NUMBER OF ¿LEAKAGE¿ ISSUES ACROSS THE VENFLON PRO SAFETY RANGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565812 BD VENFLON PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1