BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENFLON I 18GA 1.2 MM X 45MM

    MDR report key: 9247813 · Received October 28, 2019

    Report

    Report Number
    2243072-2019-02406
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    October 3, 2019
    Report Date
    November 1, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE REPORTED ISSUE OF ¿PATIENT IS GETTING FEVER AND RIGOR WHEN THE HAVE INSERTED THE VENFLON I ALSO IT IS GETTING DISLODGE AND SHOWING COMPLICATIONS LIKE PHLEBITIS WITHIN A DAY¿ WITH LOT NUMBER 9031707 REGARDING ITEM # 391593 SO THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. 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. THE TEAM INVESTIGATED RETENTION SAMPLES OF MATERIAL NUMBER 391593 FOR BATCH NUMBER 9031707. THE TEAM REVIEWED THE STERILITY CHECK REPORT AND THE BI STUDY ON THE LOT NUMBER 9031707 AND DID NOT FIND ANY DEFECT. AFTER A THOROUGH INVESTIGATION AND REVIEW OF RECEIVED COMPLAINT ON RETENTION SAMPLES AND REVIEWING THE STERILITY TEST REPORTS AND THE BI REPORT OF THE LOT NUMBER 9031707, THE TEAM FOUND THAT THE PRODUCT WAS STERILE AND SAFE FOR USE BEFORE DISPATCHING IT TO THE MARKET. DHR REVIEWED FOUND NO NON-CONFORMITIES. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED THAT BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED FAILURE. THE EXACT ROOT CAUSE CANNOT BE CONFIRMED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALLERGIC REACTION OCCURRED AFTER USE WITH A VENFLON I 18GA 1.2 MM X 45MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER (INDIA TRANSLATION), "OM MULTISPECIALITY HOSPITAL WAS USING VENFLON I (CANULA) ALL THE AREAS BUT SINCE LAST TWO DAYS THEY ARE FACING ISSUE AS THE THE PATIENT IS GETTING FEVER AND RIGER WHEN THE HAVE INSRETED THE VENFLON I ALSO IT IS GETING DISLODGE 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 OTHER BRAND OF IV CANULA AND HE IS NOT FACING ANY ISSUE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). 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 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 ALLERGIC REACTION OCCURRED AFTER USE WITH A VENFLON I 18GA 1.2 MM X 45MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER ((B)(6) TRANSLATION), "OM MULTISPECIALITY HOSPITAL WAS USING VENFLON I (CANNULA) ALL THE AREAS BUT SINCE LAST TWO DAYS THEY ARE FACING ISSUE AS THE THE PATIENT IS GETTING FEVER AND RIGER WHEN THE HAVE INSERTED THE VENFLON I ALSO IT IS GETING DISLODGE 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 OTHER BRAND OF IV CANNULA AND HE IS NOT FACING ANY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1041291 VENFLON I 18GA 1.2 MM X 45MM INTERVASCULAR CATHETER FOZ BECTON DICKINSON 9031717

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention