BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 18823107 · Received March 1, 2024

    Report

    Report Number
    3000219639-2024-00026
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    November 7, 2023
    Report Date
    March 1, 2024
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS HARMED DURING THE USE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS HARMED DURING THE USE OF THE DEVICE. THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. THE PATIENT HAD A TRACHEAL TEAR AFTER USE. BASED ON THE CUSTOMER FEEDBACK THE ETT WAS DISCARDED AT THE END OF THE PROCEDURE AS THERE WAS NO DIFFICULTY WITH THE INTUBATION OR EXTUBATION. THE INJURY WAS DISCOVERED AFTER THE TRASH HAD BEEN TAKEN OUT; THEREFORE, NO INFORMATION ON THE PRODUCT WAS PROVIDED. THE CUSTOMER INDICATED THE PRODUCT WAS AN AIRWAYS DEVICE; HOWEVER, A SPECIFIC PART NUMBER CANNOT BE DETERMINED. THERE WAS NO PART NUMBER, LOT NUMBER, PRODUCT DESCRIPTION, PHOTO IMAGES, OR VIDEO PROVIDED; THEREFORE, THE COMPLAINT WAS UNABLE TO EVALUATE. NO LOT NUMBER WAS IDENTIFIED; THEREFORE, NO INVENTORY ASSESSMENT WAS PERFORMED. THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM DATES OF NOVEMBER 8, 2021, TO NOVEMBER 8, 2023, FOR PART NAME AIRWAYS FOR FAILURE MODE "SKIN IRRITATION", THIS IS THE SECOND (2) COMPLAINT REPORTED FOR PART GROUP "AIRWAYS" REPORTED ON OCTOBER 28, 2022, FOR (B)(4) FOR PART GROUP 1-5075-26 FOR "SKIN IRRITATION." BASED ON RMA-20024B REV 1, PARKER FLEX-TIP ENDOTRACHEAL TUBES, PRODUCT RISK ANALYSIS. UNDER THE KNOWN AND FORESEEABLE HAZARDS "SCRATCHING AND TRAUMA OR TRACHEA AND MUCOSAL TISSUE" UNDER ID R10. THE POTENTIAL CAUSE(S) OF HAZARD (HAZARDOUS SITUATION) THE PATIENT END OF THE TRACHEAL TUBE AT THE BEVEL THE CUFF. 2. THE TRANSITION BETWEEN THE OUTSIDE SURFACE OF THE MAIN TUBE AND THE CUFF AT THE POINTS OF ATTACHMENT 3. SMOOTH OUTSIDE AND INSIDE SURFACES. 4. THE MURPHY EYES. THE RISK TABLE SHOWS 5 = SEVERITY, 2 = LIKELIHOOD OF OCCURRENCE, RPN = 10; THEREFORE, THE RISK LEVEL IS ACCEPTABLE. DUE TO THE LOW NUMBER OF REPORTED COMPLAINTS THIS COMPLAINT HAS A LOW RISK AS STATED IN RISK DETERMINATION CHART: (B)(4) WHICH IS ALIGNED TO THE APPROVED RISK MANAGEMENT DOCUMENTATION. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Description of Event or Problem · 0

    PT HAD A TRACHEAL TEAR.   PATIENT HAD A TRACHEAL TEAR AFTER USE. THE ITEM WAS THROWN AWAY.

    Description of Event or Problem · 0

    PT HAD A TRACHEAL TEAR.   PATIENT HAD A TRACHEAL TEAR AFTER USE. THE ITEM WAS THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237363 SALTER LABS FLEX-TIP ETT BTR SALTER LABS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other