BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMED LLC

    MDR report key: 16550260 · Received March 15, 2023

    Report

    Report Number
    1314417-2023-00007
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 27, 2023
    Report Date
    February 27, 2023
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTR
    UDI-DI
    01088483040508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS INJURED DURING EXTUBATING, THIS MAY HAVE BEEN CAUSED DUE TO IMPROPER USE BY CLINICIAN. PROPER TRAINING ON THE USE OF THE PRODUCT NEEDS TO BE DONE BEFORE USE OF PATIENT. INSTRUCTIONS ON PROPER USE OF DEVICE IS DISTRIBUTED WITH THE PRODUCT. THE CUFF NEEDS TO BE PROPERLY DEFLATED BEFORE EXTUBATING OR PATIENT INJURY WILL OCCUR. COMPLAINT NOT CONFIRMED DUE TO LACK OF PHOTO OR RM. BASED OFF OF PO#S, THE CUSTOMER IS COMPLAINT ABOUT 1-7333-30 AND/OR 1-7333-35. SENT COMPLAINT INFORMATION TO THE SUPPLIER. PULLED MOST SIMILAR AVAILABLE DEVICE PART NUMBER: 1-7333-25 TO PERFORM VISUAL INSPECTION. NO NON-CONFORMANCES WERE FOUND. REVIEWED THE COMPLAINT HISTORY FOR THE 24 MONTHS PRECEDING THE COMPLAINT REPORTING DATE. THERE WERE 0 COMPLAINTS FOR 1-7333-30 AND 1-7333-35 IN THAT TIMEFRAME. ROOT CAUSE CANNOT BE DETERMINED WITH THE LIMITED INFORMATION PROVIDED IN THE COMPLAINT. POSSIBLE ROOT CAUSE IS USER ERROR. PER THE RISK ANALYSIS PERFORMED WITH RMA-20024B, THE COMPLAINT HAS A SEVERITY RATING OF 5. SENT RESOLUTION TO THE CUSTOMER.

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS INJURED DURING EXTUBATING, THIS MAY HAVE BEEN CAUSED DUE TO IMPROPER USE BY CLINICIAN. PROPER TRAINING ON THE USE OF THE PRODUCT NEEDS TO BE DONE BEFORE USE OF PATIENT. INSTRUCTIONS ON PROPER USE OF DEVICE IS DISTRIBUTED WITH THE PRODUCT. THE CUFF NEEDS TO BE PROPERLY DEFLATED BEFORE EXTUBATING OR PATIENT INJURY WILL OCCUR.

    Description of Event or Problem · 0

    PATIENTS GETTING INJURED WHEN REMOVING ETT'S. IN ANY CASE, WHAT I HEARD WAS THAT THERE WERE 3 (I BELIEVE) INSTANCES WHERE THE PATIENT WAS EXTUBATED, AND IT SOUNDS LIKE MAYBE THE CUFF DID NOT DEFLATE PROPERLY? A POPPING SOUND WAS HEARD I THINK, AND I WAS TOLD THE PATIENT'S AIRWAYS WERE INJURED. I BELIEVE THE ISSUES ARE OCCURRING WITH EXTUBATING ONLY AND HONESTLY I AM NOT HEARING ANY ISSUES FROM ANESTHESIA. I THINK IT IS COMING FROM RESPIRATORY. SOUNDS LIKE IT MAY BE USER ERROR AND THEY ARE HANDLING IT INTERNALLY.

    Description of Event or Problem · 0

    PATIENTS GETTING INJURED WHEN REMOVING ETT'S. IN ANY CASE, WHAT I HEARD WAS THAT THERE WERE 3 (I BELIEVE) INSTANCES WHERE THE PATIENT WAS EXTUBATED, AND IT SOUNDS LIKE MAYBE THE CUFF DID NOT DEFLATE PROPERLY? A POPPING SOUND WAS HEARD I THINK, AND I WAS TOLD THE PATIENT'S AIRWAYS WERE INJURED. I BELIEVE THE ISSUES ARE OCCURRING WITH EXTUBATING ONLY AND HONESTLY I AM NOT HEARING ANY ISSUES FROM ANESTHESIA. I THINK IT IS COMING FROM RESPIRATORY. SOUNDS LIKE IT MAY BE USER ERROR AND THEY ARE HANDLING IT INTERNALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757980 SUNMED LLC CUFFED ENDOTRACHEAL TUBE BTR SUNMED HOLDINGS LLC 1-7333-30, 1-7333-35 UNKNOWN 01088483040508

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other