BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 9553733 · Received January 6, 2020

    Report

    Report Number
    8041187-2019-01073
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 19, 2019
    Report Date
    January 14, 2020
    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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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; THEREFORE THE INCIDENT COULD BE VERIFIED DUE TO LEAKAGE BEING CAUSED BY THE MOVED VALVE. 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 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, CAPA#1298780, 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED BLOOD OUT OF THE OPEN INJECTION PORT AFTER THE CATHETER WAS PLACED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: BLOODS FLOWS OUT OF THE OPEN INJECTION PORT AFTER THE CATHETER WAS PLACED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER LEAKED BLOOD OUT OF THE OPEN INJECTION PORT AFTER THE CATHETER WAS PLACED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: BLOODS FLOWS OUT OF THE OPEN INJECTION PORT AFTER THE CATHETER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19008 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9241386

    Patients

    Seq Age Sex Outcome Treatment
    1 Other