BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX

    MDR report key: 10587560 · Received September 25, 2020

    Report

    Report Number
    3012307300-2020-09818
    Event Type
    Injury
    Date Received
    September 25, 2020
    Report Date
    December 3, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTR
    UDI-DI
    15019315022340
    PMA / PMN Number
    K790312
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: FIFTY FIVE UNUSED PORTEX ENDOTRACHEAL TUBES WERE RETURNED FOR ANALYSIS. THE RETURNED SAMPLES WERE VISUALLY INSPECTED AT A DISTANCE OF 12? TO 16? AND NORMAL CONDITIONS OF ILLUMINATION. NO DISCREPANCIES WERE OBSERVED. THE RETURNED SAMPLES WERE INFLATED USING A SYRINGE AND SUBMERGED UNDER WATER IN ORDER TO DETECT ANY INFLATION ISSUE. NO INFLATION ISSUES WERE FOUND IN THE 55 SAMPLES. PRODUCTION PERSONNEL PERFORMS A 100 PERCENT VISUAL INSPECTION TO THE CUFF. QUALITY TAKES A SAMPLE USING AN AQL 1.0 AND A LEVEL INSPECTION G-I IN ORDER VERIFY THE VISUAL INSPECTION AND AUDIT LEAK TEST. THE REPORTED ISSUE WAS NOT CONFIRMED. NO CORRECTIVE ACTIONS WERE TAKEN SINCE THE COMPLAINT WAS NOT CONFIRMED. DEVICE HISTORY REPORT: PART NUMBER = 100 199/080; LOT NUMBER = 3874480; QTY RELEASED = (B)(4).; MFG DATE = OCTOBER 2019; IDR, DMR OR DA = N/A.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED THAT A TUBE CHANGE OUT HAD TO BE PERFORMED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT WHEN THE PORTEX ENDOTRACHEAL TUBE WAS INSERTED INTO THE PATIENT AND INFLATED AS PER NORMAL PROCEDURE, WHILE THE OPERATION WAS IN PROCESS THE CUFF DEFLATED. THERE WERE NO ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050768 PORTEX TRACHEOSTOMY TUBE BTR SMITHS MEDICAL INTERNATIONAL, LTD. 100/199/080 3874480 15019315022340

    Patients

    Seq Age Sex Outcome Treatment
    1