BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENFLON PRO SAFETY 18GA 1.3MM OD 32MM L

    MDR report key: 12316113 · Received August 12, 2021

    Report

    Report Number
    8041187-2021-00713
    Event Type
    Malfunction
    Date Received
    August 12, 2021
    Date of Event
    August 16, 2020
    Report Date
    September 8, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 9297926 D4: MEDICAL DEVICE EXPIRATION DATE: 2022-10-31 H4: DEVICE MANUFACTURE DATE: 2022-10-31 D4: MEDICAL DEVICE LOT #: 9297977 D4: MEDICAL DEVICE EXPIRATION DATE: 2022-10-31 H4: DEVICE MANUFACTURE DATE: 2022-10-31 H6: INVESTIGATION SUMMARY PHOTOS IN A PDF WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE PHOTOS IN THE PDF ARE NOT CLEAR AND THE TEAM IS UNABLE TO LOCATE THE BD PRODUCT IN THESE PHOTOS. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. AS NO CLEAR PHOTOS OR SAMPLES WERE RECEIVED, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED VENFLON PRO SAFETY 18GA 1.3MM OD 32MM L HAD A NEEDLE BREAKAGE, REQUIRING MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN: "THE PURPOSE OF THE FOLLOWING INVESTIGATIONS IS TO DETERMINE THE CAUSE OF THE RUPTURE THAT OCCURRED ON A SAFETY CANNULA NEEDLE WHEN IT WAS INSERTED ON A PATIENT.".

    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 VENFLON PRO SAFETY 18GA 1.3MM OD 32MM L HAD A NEEDLE BREAKAGE, REQUIRING MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THE PURPOSE OF THE FOLLOWING INVESTIGATIONS IS TO DETERMINE THE CAUSE OF THE RUPTURE THAT OCCURRED ON A SAFETY CANNULA NEEDLE WHEN IT WAS INSERTED ON A PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213028 VENFLON PRO SAFETY 18GA 1.3MM OD 32MM L INTRAVASCULAR CATHETER FOZ SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention