BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID

    MDR report key: 14137977 · Received April 18, 2022

    Report

    Report Number
    3012307300-2022-06559
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    August 23, 2021
    Report Date
    May 20, 2022
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019315104862
    PMA / PMN Number
    K030570
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: ONE USED DECONTAMINATED SAMPLE 007/910/880 8MM BLU SUCTIONAID SUB-ASSY WAS RETURNED FOR INVESTIGATION WITHOUT ITS ORIGINAL PACKAGING (SEE PHOTO OF SAMPLE). UNDER VISUAL INSPECTION WE NOTICED THAT SUCTION TUBING HAS TIP FORMED END IN SUCTION CONNECTOR WHICH IS CAUSING REPORTED OCCLUSION. EACH SUCTION LINE ASSEMBLY SHALL BE INSPECTED AS PER PWI-10001168 REV. 105 OPERATOR QUALITY CHECK NO. 4.2: "FLOW TEST EACH SUB-ASSEMBLY, PLACE THE TAPERED END OF THE CONNECTOR ON TO THE TEST NOZZLE, AND VISUALLY CONFIRM THAT THE TOP OF THE FLOW INDICATOR IS ABOVE THE MINIMUM FLOW REQUIREMENT OF 4 LTR/MIN @ 70 MBAR PRESSURE." TESTING WAS REPLICATED ON RETURNED SAMPLE BY MANUFACTURING QUALITY ENGINEER (B)(6) (FLOW METER G:01874-CZ). IT WAS FOUND THAT FLOW IS OCCLUDED AND DO NOT MEET MINIMUM AIR FLOW. THE CUSTOMER STATED PROBLEM WAS DUPLICATED. THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS. ANY OTHER SIMILAR CUSTOMER COMPLAINT HAS NOT BEEN RECEIVED AGAINST SMITHS MEDICAL CZECH REPUBLIC SUCTION LINE PRODUCTION THEREFORE THIS INCIDENT IS CONSIDERED TO BE ISOLATED FAILURE ONLY. ALL OPERATORS WHO ARE WORKING ON AFFECTED WORKPLACE WERE INFORMED BY MANUFACTURING QUALITY ENGINEER (B)(6). FURTHER MORE QUALITY ALERT WHICH IS DESCRIBING WHAT WAS HAPPENED WAS PLACED ON AFFECTED WORKPLACE. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUCTION LINE IS CLOGGED. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606006 PORTEX BLUE LINE ULTRA SUCTIONAID TUBE, TRACHEAL (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/870/080CZ 4039626 15019315104862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown