BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VENFLON¿ IV CANNULA

    MDR report key: 9213527 · Received October 21, 2019

    Report

    Report Number
    2243072-2019-02334
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    October 3, 2019
    Report Date
    November 1, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THE TEAM INVESTIGATED THE RETENTION SAMPLES OF MATERIAL NUMBER 391591 FOR BATCH NUMBER 9031707. THE TEAM REVIEWED THE STERILITY CHECK REPORT AND THE BI STUDY ON THE LOT NUMBER 9031707 AND WE DID NOT FIND ANY DEFECT IN THE RETENTION SAMPLES. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS NOT ABLE TO CONFIRM THE INDICATED FAILURE. THE EXACT ROOT CAUSE CANNOT BE CONFIRMED. DHR REVIEWED FOUND NO NON-CONFORMITIES. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VENFLON¿ IV CANNULA WAS USED AND THE PATIENT HAD AN ALLERGIC REACTION. THIS OCCURRED ON 10 OCCASIONS AFTER USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL WAS USING VENFLON I (CANULA) ALL THE AREAS BUT SINCE LAST TWO DAYS THEY ARE FACING ISSUE AS THE PATIENT IS GETTING FEVER AND RIGER WHEN THE HAVE INSERTED THE VENFLON I ALSO IT IS GETTING DISLODGED AND SHOWING COMPLICATIONS LIKE PHLEBITIS WITHIN A DAY AND DUE TO WHICH DR. HAS TO POSTPONED THE SURGERY IN THEIR TWO TO THREE PATIENT AS IT HAD SHOWING SIMILAR ISSUE IN ALL, THE DOCTOR HAD STOP USING OUR BRAND AND STARTED USING ROMSONS IV CANULA AND HE IS NOT FACING ANY ISSUE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(6). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 BD VENFLON¿ IV CANNULA WAS USED AND THE PATIENT HAD AN ALLERGIC REACTION. THIS OCCURRED ON 10 OCCASIONS AFTER USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL WAS USING VENFLON I (CANULA) ALL THE AREAS BUT SINCE LAST TWO DAYS THEY ARE FACING ISSUE AS THE PATIENT IS GETTING FEVER AND RIGER WHEN THE HAVE INSERTED THE VENFLON I ALSO IT IS GETTING DISLODGED AND SHOWING COMPLICATIONS LIKE PHLEBITIS WITHIN A DAY AND DUE TO WHICH DR. HAS TO POSTPONED THE SURGERY IN THEIR TWO TO THREE PATIENT AS IT HAD SHOWING SIMILAR ISSUE IN ALL, THE DOCTOR HAD STOP USING OUR BRAND AND STARTED USING ROMSONS IV CANULA AND HE IS NOT FACING ANY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009691 BD VENFLON¿ IV CANNULA NEEDLE FMI BECTON DICKINSON 9031707

    Patients

    Seq Age Sex Outcome Treatment
    1 Other