BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 15955793 · Received December 9, 2022

    Report

    Report Number
    8041187-2022-00715
    Event Type
    Malfunction
    Date Received
    December 9, 2022
    Date of Event
    November 15, 2022
    Report Date
    January 18, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 04-JAN-2022. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS FAILURE CANNOT BE DETERMINED. ALL SAMPLES PASSED OUR INTERNAL LEAKAGE TESTING, AND NO ABNORMALITIES WERE OBSERVED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2173250 MEDICAL DEVICE EXPIRATION DATE: 2025-06-30, DEVICE MANUFACTURE DATE: 2022-07-20. MEDICAL DEVICE LOT #: 2201267, MEDICAL DEVICE EXPIRATION DATE: 2025-07-31, DEVICE MANUFACTURE DATE: 2022-08-01. 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 18 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROBLEM IS THAT THE INFUSION FLOWS INTO THE DRESSING AND NOT INTO THE VEIN. DIE CANNULAS ARE ALL LEAKING AT THE WINGS USED TO FIXATE THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 18 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PROBLEM IS THAT THE INFUSION FLOWS INTO THE DRESSING AND NOT INTO THE VEIN. DIE CANNULAS ARE ALL LEAKING AT THE WINGS USED TO FIXATE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2523950 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown