BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE

    MDR report key: 9549557 · Received January 3, 2020

    Report

    Report Number
    3012307300-2020-00026
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 5, 2019
    Report Date
    March 11, 2020
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE WAS RETURNED FOR ANALYSIS IN USED CONDITION. NO DISCREPANCIES WERE FOUND UPON VISUAL INSPECTION. THE CUFF WAS INFLATED USING A SYRINGE WHILE IT WAS SUBMERGED UNDERWATER; A BURBLE WAS OBSERVED COMING FROM A SMALL TEAR IN THE CUFF. RELEVANT DOCUMENTS AND THE MANUFACTURING PROCESS WERE BOTH REVIEWED AND DEEMED ADEQUATE. THE CUFF ASSEMBLY OPERATION AND THE INFLATION LINE ASSEMBLY OPERATION WERE REVIEWED; NO DISCREPANCIES WERE FOUND. THE INFLATION TESTING PROCESS WAS AUDITED OF 32 UNITS FROM THE PRODUCTION FLOOR; NO DEFLATED CUFFS WERE DETECTED. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE IS DUE TO USER INTERFACE AS THE MOST PROBABLE CAUSE IS THAT THE TEAR IN THE CUFF OCCURRED DURING TRACHEOSTOMY PROCEDURE.

    Additional Manufacturer Narrative · 1

    TWO COMPLAINTS FILED TO REFLECT REPORTED AIR LEAKAGE FROM TWO TUBES. 3012307300-2020-00026-0061455, 3012307300-2020-00024-0061243.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT ONE DAY FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE, AIR WAS OBSERVED LEAKING FROM THE TUBE. THE TUBE WAS THEN REPLACED BUT AIR LEAKAGE OCCURRED AGAIN. SUBSEQUENTLY, A THIRD TRACH TUBE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11743 PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD; INC. 3791003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention