BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO 1.3MM X 45MM

    MDR report key: 9554825 · Received January 6, 2020

    Report

    Report Number
    8041187-2019-01074
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 11, 2019
    Report Date
    February 4, 2020
    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
    BG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION, A DEFORMED PACKAGE WITH AN OPEN SEAL NEAR THE END CAP WAS OBSERVED; THEREFORE, THE INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. THE MANUFACTURING PROCESS HAS BEEN REVIEWED. THESE BATCHES WERE PACKED BY MANUAL PACK PROCESS, THE OPERATOR WOULD HAVE DETECTED THE REPORTED DEFECT DURING THE MANUAL PACK PROCESS. THE REPORTED DEFECT COULD HAVE HAPPENED OUT OF MANUFACTURING PLANT. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STERILE BREACH WAS FOUND BEFORE USE WITH A VENFLON PRO 1.3MM X 45MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PACKAGE BROKEN, CANNULA AFFECTED." 74 OCCURRENCES REPORTED.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 834090. MEDICAL DEVICE EXPIRATION DATE: 2021-11-30. DEVICE MANUFACTURE DATE: 2019-01-04. MEDICAL DEVICE LOT #: 8356893. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2019-01-18. 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 STERILE BREACH WAS FOUND BEFORE USE WITH A VENFLON PRO 1.3MM X 45MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PACKAGE BROKEN, CANNULA AFFECTED." 74 OCCURRENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18919 VENFLON PRO 1.3MM X 45MM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE. H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other