BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ IV CANNULA

    MDR report key: 12356911 · Received August 23, 2021

    Report

    Report Number
    2243072-2021-02165
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    July 27, 2021
    Report Date
    August 31, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿CANNULA INSERTED DIFFICULT TO CANNULATE CHILD. IMMEDIATELY NOTICED BLOOD LEAKING FROM POINT AT WHICH HUB MEETS CANNULA TUBING. FLUSHED VIA TOP PORT, AND FLUSH LEAKED OUT OF CANNULA. CANNULA THEN REMOVED AND KEPT TO TEST. CANNULA AND PACKAGING HAS BEEN KEPT AND IS BEING STORED AT ECH. HARM TO PATIENT WAS THAT FURTHER REPEATED CANNULATION ATTEMPTS WERE THEN REQUIRED¿ WITH LOT NUMBER 0112791 REGARDING ITEM # 391451, SO RETENTION SAMPLES WERE USED FOR THE INVESTIGATION. THE DHR OF LOT NUMBER 391451 AND BATCH NUMBER OF 0.0112791 WAS REVIEWED AND NO QUALITY NOTIFICATION WAS FOUND ON THIS LOT NUMBER. THE INVESTIGATION TEAM HAS CARRIED OUT THE SIMULATION OF THE COMPLAINT ON THE TEN RETENTION SAMPLES OF PRODUCT MATERIAL CODE 391451 AND LOT NUMBER 0112791. BASED ON THE SIMULATION CARRIED OUT ON THE VENFLON 22GA RETENTION SAMPLE THE DEFECT COULD NOT BE CONFIRMED. THE PROBABLE ROOT CAUSE COULD NOT BE CONFIRMED. BD COULD NOT INVESTIGATE OR CONFIRM THE ROOT CAUSE OF THE REPORTED DEFECT DUE TO LACK OF ORIGINAL SAMPLE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VENFLON¿ IV CANNULA EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANNULA INSERTED INTO DIFFICULT TO CANNULATE CHILD. IMMEDIATELY NOTICED BLOOD LEAKING FROM POINT AT WHICH HUB MEETS CANNULA TUBING. FLUSHED VIA TOP PORT, AND FLUSH LEAKED OUT OF CANNULA. CANNULA THEN REMOVED AND KEPT TO TEST. HARM TO PATIENT WAS THAT FURTHER REPEATED CANNULATION ATTEMPTS WERE THEN REQUIRED.

    Additional Manufacturer Narrative · 1

    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 THE BD VENFLON¿ IV CANNULA EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CANNULA INSERTED INTO DIFFICULT TO CANNULATE CHILD. IMMEDIATELY NOTICED BLOOD LEAKING FROM POINT AT WHICH HUB MEETS CANNULA TUBING. FLUSHED VIA TOP PORT, AND FLUSH LEAKED OUT OF CANNULA. CANNULA THEN REMOVED AND KEPT TO TEST. HARM TO PATIENT WAS THAT FURTHER REPEATED CANNULATION ATTEMPTS WERE THEN REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252950 BD VENFLON¿ IV CANNULA INTERVASCULAR CATHETER FOZ 0112791

    Patients

    Seq Age Sex Outcome Treatment
    1