BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENFLON I 20GA 1.0 MM X 32MM

    MDR report key: 9213628 · Received October 21, 2019

    Report

    Report Number
    2243072-2019-02336
    Event Type
    Injury
    Date Received
    October 21, 2019
    Date of Event
    October 3, 2019
    Report Date
    November 5, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    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: 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 9122513 AND 9094813 REGARDING ITEM # 391592 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 391592 FOR BATCH NUMBER 9122513 AND 9094813. THE TEAM REVIEWED THE STERILITY CHECK REPORT AND THE BI STUDY ON THE LOT NUMBER 9122513 AND 9094813 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 9122513 AND 9094813, THE TEAM FOUND THAT THE PRODUCT WAS STERILE AND SAFE FOR USE BEFORE DISPATCHING IT TO THE MARKET. 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. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENFLON I 20GA 1.0 MM X 32MM BACKED OUT OF THE VEIN AFTER USE, AND THE PATIENT DEVELOPED "PHLEBITIS" IN ADDITION TO "FEVER", AND "RIGGER" WHEN THE VENFLON WAS INSERTED. THE PATIENT'S SURGERY WAS POSTPONED AS A RESULT OF THE EVENT. LOT #'S 9122513 AND 9094813 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, EACH WITH ONE OCCURRENCE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL WAS USING VENFLON I (CANNULA) ALL THE AREAS BUT SINCE LAST TWO DAYS THEY ARE FACING ISSUE AS THE PATIENT IS GETTING FEVER AND RIGGER WHEN THE HAVE INSERTED THE VENFLON I ALSO IT IS GETTING DISLODGE AND SHOWING COMPLICATIONS LIKE PHLEBITIS WITHIN A DAY DUE TO WHICH DR. HAS TO POSTPONE THE SURGERY.

    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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9122513; EXPIRATION DATE: 2024-04-30; MANUFACTURE DATE: 2019-05-02. MEDICAL DEVICE LOT #: 9094813; EXPIRATION DATE: 2024-03-31; MANUFACTURE DATE: 2019-04-04, 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 VENFLON I 20GA 1.0 MM X 32MM BACKED OUT OF THE VEIN AFTER USE, AND THE PATIENT DEVELOPED "PHLEBITIS" IN ADDITION TO "FEVER", AND "RIGGER" WHEN THE VENFLON WAS INSERTED. THE PATIENT'S SURGERY WAS POSTPONED AS A RESULT OF THE EVENT. LOT #'S 9122513 AND 9094813 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, EACH WITH ONE OCCURRENCE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL WAS USING VENFLON I (CANNULA) ALL THE AREAS BUT SINCE LAST TWO DAYS THEY ARE FACING ISSUE AS THE PATIENT IS GETTING FEVER AND RIGGER WHEN THE HAVE INSERTED THE VENFLON I ALSO IT IS GETTING DISLODGE AND SHOWING COMPLICATIONS LIKE PHLEBITIS WITHIN A DAY DUE TO WHICH DR. HAS TO POSTPONE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007914 VENFLON I 20GA 1.0 MM X 32MM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention