BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMED LLC

    MDR report key: 16773055 · Received April 19, 2023

    Report

    Report Number
    1314417-2023-00008
    Event Type
    Injury
    Date Received
    April 19, 2023
    Date of Event
    February 24, 2023
    Report Date
    April 19, 2023
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTR
    UDI-DI
    10889483040508
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE AS REPORTED TO FDA, AND THE PATIENT NEEDED RACEMIC EPI TREATMENT FOR STRIDOR.

    Additional Manufacturer Narrative · 0

    REPORTABLE AS REPORTED TO FDA, AND THE PATIENT NEEDED RACEMIC EPI TREATMENT FOR STRIDOR. COMPLAINT NOT CONFIRMED AS NO PHOTO OR RETURNED MATERIAL WAS PROVIDED. SENT COMPLAINT INFORMATION TO THE SUPPLIER. REVIEWED COMPLAINT HISTORY FOR THE 24 MONTHS PRECEDING THE COMPLAINT REPORTING DATE. THERE WAS ONE COMPLAINT FOR THE PART IN THAT TIMEFRAME, THERE IS NO TRENDING ISSUE. ROOT CAUSE OF NOISE IS LIKELY DUE TO ONE OF THE FOLLOWING: THE CUFF WAS AT LEAST PARTIALLY INFLATED, OR THE CUFF SNAGGED ON SOMETHING SUCH AS SCAR TISSUE OR A TUMOR IN THE AIRWAY. PULLED MOST SIMILAR AVAILABLE DEVICE PART NUMBER 1-7333-25 TO PERFORM VISUAL INSPECTION. NO NON-CONFORMANCES WERE FOUND. SENT RESOLUTION TO THE CUSTOMER.

    Description of Event or Problem · 0

    CLINICIAN FELT A "POPPING" AS THE CUFF WAS BEING REMOVED. THE PATIENT NEEDED RACEMIC EPI FOR STRIDOR LATER IN THE DAY.

    Description of Event or Problem · 0

    CLINICIAN FELT A "POPPING" AS THE CUFF WAS BEING REMOVED. THE PATIENT NEEDED RACEMIC EPI FOR STRIDOR LATER IN THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442170 SUNMED LLC E/T TUBE CUFFED 3.0MM 12FR BTR SUNMED HOLDINGS LLC 1-7333-30 10889483040508

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other