BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU)

    MDR report key: 9988253 · Received April 22, 2020

    Report

    Report Number
    3012307300-2020-03234
    Event Type
    Injury
    Date Received
    April 22, 2020
    Date of Event
    January 1, 2020
    Report Date
    April 24, 2020
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RETURNED FOR INVESTIGATION . THIS IS A CORRECTIVE REPORT ON LEGAL AND MANUFACTURING. NO LOT NUMBER WAS PROVIDED OR UDI.

    Description of Event or Problem · 1

    (2/2 REFERENCE (B)(4) FOR ALL ATTACHMENTS AND RELATED COMPLAINTS). SMJ#CFFF107. DURING THE USE OF THE PRODUCT (A TUBE), BRACHIOCEPHALIC ARTERY FISTULA OCCURRED IN THE PATIENT. THE CUSTOMER SUSPECTED THAT SOMETHING WAS WRONG WITH THE LENGTH AND THE ANGLE OF THE PRODUCT. THEREFORE, THEY SWITCHED IT TO COMPETITOR'S ONES. THE AFFECTED ITEM IS EITHER 100/860, 100/811, OR 100/800.

    Description of Event or Problem · 1

    THIS IS CORRECTIVE DATA ON MDR SUBMISSION. THE COMPLAINT OF DURING THE USE OF THE PRODUCT (A TUBE), BRACHIOCEPHALIC ARTERY FISTULA OCCURRED IN THE PATIENT. THE CUSTOMER SUSPECTED THAT SOMETHING WAS WRONG WITH THE LENGTH AND THE ANGLE OF THE PRODUCT. THEREFORE, THEY SWITCHED IT TO COMPETITOR'S ONES. FISTULA CAN CAUSE SERIOUS INJURY AND TO THE TRACHEA AND BLEEDING THAT MAY REQUIRE SURGICAL INTERVENTION. HOWEVER, NO FURTHER INFORMATION SUGGESTS BLEEDING OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452640 TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) TUBE TRACHEOSTOMY AND TUBE CUFF JOH UNKOWN UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention