BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX

    MDR report key: 8917764 · Received August 21, 2019

    Report

    Report Number
    3012307300-2019-04214
    Event Type
    Injury
    Date Received
    August 21, 2019
    Date of Event
    February 13, 2019
    Report Date
    August 21, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: TWO USED TRACHEOSTOMY TUBES (PART NUMBERS 007/910/680 AND 007/910/690) WERE RECEIVED FOR INVESTIGATION WITHOUT THEIR ORIGINAL PACKAGING. UNDER VISUAL INSPECTION THE INVESTIGATOR NOTICED THAT BOTH THE RETURNED DEVICES HAD SEVERAL CUFF TEARS. THE CUFFS FAILED TO INFLATE AS A RESULT. THE MOST PROBABLE CAUSE OF THIS ISSUE IS THAT THE CUFF TEARS RESULTED FROM CONTACT WITH SHARP EDGES THAT EITHER OCCURRED DURING OR AFTER TRACHEOSTOMY PROCEDURE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUFF COMPONENT OF THE TRACHEOSTOMY TUBE HAD A LEAK. A TRACHEOSTOMY TUBE CHANGE OUT WAS PERFORMED AS A RESULT. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707972 PORTEX TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC 3537483

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention