BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SOFT SEAL CUFF TRACHEAL TUBES

    MDR report key: 15522366 · Received October 1, 2022

    Report

    Report Number
    3012307300-2022-20573
    Event Type
    Malfunction
    Date Received
    October 1, 2022
    Date of Event
    September 1, 2022
    Report Date
    June 12, 2023
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTR
    UDI-DI
    15019315022319
    PMA / PMN Number
    K790312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. DEVICE EVALUATION: TWO PHOTOS WERE INCLUDED IN AGILE ATTACHMENTS FOR EVALUATION; PHOTOS SHOWED AN INFLATION LINE OCCLUDED. ONE SAMPLE WAS RETURNED FOR INVESTIGATION. THE RETURNED SAMPLE WAS RECEIVED IN USED CONDITION WITHOUT ORIGINAL PACKAGING. THE SAMPLE WAS VISUALLY INSPECTED UNDER NORMAL CONDITIONS OF ILLUMINATION TO DETECT ANY CONDITION THAT COULD CAUSE THE FAILURE MODE REPORTED. THE INFLATION LINE APPEARED OCCLUDED. THE SAMPLE WAS INFLATED USING A SYRINGE. THE CUFF DID NOT READILY INFLATE; THE COMPLAINT WAS CONFIRMED. THE SAMPLE RETURNED WAS CONNECTED TO A LEAK TESTER MACHINE TO IDENTIFY ANY OCCLUSION. OCCLUSION WAS DETECTED. BASED ON THE ANALYSIS CONDUCTED IN THE SAMPLE PROVIDED, CUFF INFLATION/DEFLATION FAILURE MODE WAS CONFIRMED. THE FAILURE CONDITION WAS POSSIBLY DUE TO ASSEMBLY PROCESS NOT FOLLOWED CORRECTLY. FAILURE WAS TRACED TO MANUFACTURING. FOR CORRECTIVE ACTION AN AWARENESS/CUSTOMER COMPLAINT NOTIFICATION WAS PERFORMED TO PRODUCTION PERSONNEL TO EXPLAIN THE IMPORTANCE OF ADHERENCE TO MANUFACTURING PROCEDURE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) AS A RESULT OF WARNING LETTER CMS# (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED THE CUFF WOULD NOT BE INFLATED. SO HE CHANGED IT TO ANOTHER ONE. AFTER THE MEDICAL OPERATION, THE CUSTOMER CHECKED THE COMPLAINT PRODUCT AGAIN, BUT THIS TIME, IT WAS SUCCESSFULLY INFLATED. SO HE SUSPECTED THERE HAD BEEN A TEMPORARY ANOMALY IN IT. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2479278 PORTEX SOFT SEAL CUFF TRACHEAL TUBES TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL INTERNATIONAL, LTD. 100/199 4274646 15019315022319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown