BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L

    MDR report key: 9356006 · Received November 21, 2019

    Report

    Report Number
    8041187-2019-00933
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 5, 2019
    Report Date
    December 19, 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
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE ACTUAL SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION OF THE SAMPLE IT WAS OBSERVED THAT THE VALVE UNDER THE PORT HAD MOVED; THEREFORE THE INCIDENT COULD BE VERIFIED. 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 CASE 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 1298780. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTION OF VENFLON PRO SAFETY IT WORKED WITHOUT PROBLEMS. AT SOME TIME, THE ANESTHESIA NURSE CHECKS THE ADMISSION OF HER PATIENTS PVK AND HERE SHE DISCOVERED THAT A POWERFUL BLOOD STREAM IS RUNNING OUT OF THE CHIMNEY.

    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 AN UNSPECIFIED NUMBER OF VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTION OF VENFLON PRO SAFETY IT WORKED WITHOUT PROBLEMS. AT SOME TIME, THE ANESTHESIA NURSE CHECKS THE ADMISSION OF HER PATIENTS PVK AND HERE SHE DISCOVERED THAT A POWERFUL BLOOD STREAM IS RUNNING OUT OF THE CHIMNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154519 VENFLON PRO SAFETY 20GA 1.1MM OD 32MM L INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9208017

    Patients

    Seq Age Sex Outcome Treatment
    1 Other