BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX CLEAR SOFT SEAL CUFF TRACHEAL TUBE

    MDR report key: 8150179 · Received December 11, 2018

    Report

    Report Number
    3012307300-2018-08535
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 1, 2018
    Report Date
    January 15, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTR
    UDI-DI
    55019315022331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: ONE TRACHEOSTOMY (TRACH) SAMPLE WAS RECEIVED IN USED CONDITION WITHOUT THE ORIGINAL PACKAGING. IMMEDIATE VISUAL INSPECTION DID NOT DETECT ANY DAMAGE. A LEAK AND INFLATION TEST WAS COMPLETED AND LEAKAGE OCCURRED DUE TO A SMALL TEAR FOUND IN THE CUFF. THE CUFF ASSEMBLY OPERATION AND INFLATION LINE ASSEMBLY WERE REVIEWED WITH NO DISCREPANCIES. INFLATION TESTS WERE AUDITED DURING THIRTY TWO (32) UNITS FINDING NO DEFLATED CUFFS. A REVIEW OF THE MANUFACTURING PROCESS WAS CONDUCTED AND WAS CONSIDERED ADEQUATE AND CORRECT. BASED ON THE EVIDENCE AND TESTING, THE COMPLAINT WAS CONFIRMED. NO PROBLEM SOURCE COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING THE USE OF A SMITHS MEDICAL INTUBATION TUBE, A LEAK OCCURRED. A TUBE REPLACEMENT WAS REQUIRED. NO PATIENT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993520 PORTEX CLEAR SOFT SEAL CUFF TRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL ASD, INC. 55019315022331

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention