BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK)

    MDR report key: 1203205 · Received October 10, 2008

    Report

    Report Number
    2936485-2008-00085
    Event Type
    Malfunction
    Date Received
    October 10, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HIF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RECEIVED FOR INVESTIGATION IN OVER 25 DAYS. A DETAILED INVESTIGATION CANNOT BE PERFORMED WITHOUT THE PRODUCT. THE ROOT CAUSE OF THIS FAILURE MODE IS INADEQUATE GLUING OF THE PLASTIC PART TO THE MAIN INSUFFLATION. THE MOST LIKELY ROOT CAUSE IS THE PLASTIC PART TO WHICH THE LUER LOCK IS CONNECTED TO WHICH IN TURN CONNECTS TO THE MAIN INSUFFLATION TUBING CAME UNGLUED FROM THE MAIN INSUFFLATION TUBING. PROBABLE ROOT CAUSE: INADEQUATE GLUING DURING MANUFACTURING CA/PA: CONTINUE MONITORING AND TRENDING SUCH COMPLAINTS. CURRENTLY, CHANGES/IMPROVEMENTS ARE BEING MADE TO THE GLUING PROCESS AT THE OEM VENDOR TO AVOID SUCH FAILURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LUER LOCK OF THE TUBING DISCONNECTED DURING A CASE. THE TUBING WAS SWITCHED OUT AND CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FLOW II TUBESET FOR PNEUMO SURE (10-PK) TUBESET HIF STRYKER ENDOSCOPY SAN JOSE 0641071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK