BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA 20G/45MM

    MDR report key: 12178572 · Received July 15, 2021

    Report

    Report Number
    8041187-2021-00597
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 16, 2021
    Report Date
    September 23, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ARTERIAL CANNULA 20G/45MM FLOW SWITCH WAS NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT´S NOT POSSIBLE TO CLOSE THE RED FLOW SWITCH. WHEN THE FLOW SWITCH CANT BE CLOSED IT IS A BIG CONCERN OF BLOOD CONTAMINATION OF THE STAFF AND LOSS OF BLOOD FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9352802, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2019-12-18, MEDICAL DEVICE LOT #: 1053388, MEDICAL DEVICE EXPIRATION DATE: 2026-02-28, DEVICE MANUFACTURE DATE: 2021-02-22. 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 ARTERIAL CANNULA 20G/45MM FLOW SWITCH WAS NOT WORKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT´S NOT POSSIBLE TO CLOSE THE RED FLOW SWITCH. WHEN THE FLOW SWITCH CANT BE CLOSED IT IS A BIG CONCERN OF BLOOD CONTAMINATION OF THE STAFF AND LOSS OF BLOOD FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068772 ARTERIAL CANNULA 20G/45MM INTRAVASCULAR CATHETER FOZ SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1