BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID

    MDR report key: 14345756 · Received May 10, 2022

    Report

    Report Number
    3012307300-2022-08332
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 8, 2022
    Report Date
    June 20, 2023
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019315104862
    PMA / PMN Number
    K030570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. ONE USED DECONTAMINATED SAMPLE 007/910/880 8MM BLU SUCTIONAID SUB-ASSY WITH A TERUMO BRAND SYRINGE (NOT PART OF FINISH GOOD KIT 100/870/080CZ) WERE RECEIVED. UNDER VISUAL INSPECTION SUCTION CONNECTOR SEEMS TO BE WITHOUT ANY DEFECT. THEN A SYRINGE WAS INSERTED INTO THE CONNECTOR AND CRACK IN CONNECTOR SPLIT LINE WAS OBSERVED. INSPECTION PROCESS WHICH IS ABLE TO DETECT SUCH DAMAGE IS IN PLACE. DURING MANUFACTURING PROCESS WHICH IS DESCRIBED IN PWI-10003123 REV. 102 SUCTION CONNECTORS ARE PERIODICALLY INSPECTED (1PCS FROM EACH CAVITY WHEN PRODUCTION STARTS AND THEN EVERY 4 HOURS AND AFTER ANY MACHINE STOPPAGE). PART OF INSPECTION IS FUNCTIONAL TEST BY THE HELP OF 6% LUER TAPER GAUGE WITH WEIGHT 500G. HISTORY OF MCZH NCMRS WAS CHECKED AND THERE WAS FOUND NO PROBLEM RELATED TO SUCTION CONNECTOR SPLITTING. OCCURRENCE OF THIS DEFECT IS VERY LOW (THIS IS THE THIRD COMPLAINT AGAINST (B)(4) PRODUCTION, PREVIOUS COMPLAINTS (B)(4). ROOT CAUSE OF THIS DEFECT IS CURRENTLY UNKNOWN - IT COULD BE A MOULDING DEFECT OR EXCESSIVE FORCE USED WHEN CONNECTOR WAS CONNECTED WITH SYRINGE. 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 THERE IS A VISIBLE SPLIT IN THE CUFF'S SUCTION PORT WHILE USING A LUER LOCK SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294840 PORTEX BLUE LINE ULTRA SUCTIONAID TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL INTERNATIONAL, LTD. 100/870/080CZ 4121481 15019315104862

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention