BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9496403 · Received December 19, 2019

    Report

    Report Number
    8041187-2019-01024
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    December 4, 2019
    Report Date
    December 30, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO AND ONE VIDEO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE VIDEO IT WAS OBSERVED THAT THE VALVE UNDER THE PORT HAD MOVED WHICH COULD BE THE REASON FOR THE LEAKAGE; THEREFORE, THE INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCE'S ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE LEAKAGE IS DUE TO THE INJECTION VALVE MOVING WITHIN THE CANNULA HUB. A TREND FOR THE MOVING INJECTION VALVE HAS BEEN OBSERVED FOR THIS PRODUCT LINE. A PROJECT HAS BEEN STARTED TO FURTHER DETERMINE THE REASON FOR THE MOVING INJECTION VALVE IN THE VENFLON PRO SAFETY SO THAT A FIX CAN BE MADE TO FURTHER PREVENT THIS ISSUE. CAPA#(B)(4) HAS BEEN INITIATED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: RETURN FLOW VIA THE INJECTION VALVE. BLOOD AND INFUSION RETURNS TO THE INJECTION VALVE - VALVE MECHANISM IS DEFECTIVE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 LEAKAGE OCCURRED DURING USE WITH A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: RETURN FLOW VIA THE INJECTION VALVE. BLOOD AND INFUSION RETURNS TO THE INJECTION VALVE - VALVE MECHANISM IS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294542 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9184022

    Patients

    Seq Age Sex Outcome Treatment
    1 Other