BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMED LLC

    MDR report key: 19084525 · Received April 10, 2024

    Report

    Report Number
    1314417-2024-00019
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 7, 2024
    Report Date
    April 10, 2024
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    CAT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE INTERFERED WITH THE PATIENT RECEIVING TUBING. WAS ABLE TO RECONNECT THE TUBING WITHOUT HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 0

    THE ISSUE INTERFERED WITH THE PATIENT RECEIVING TUBING. WAS ABLE TO RECONNECT THE TUBING WITHOUT HARM TO THE PATIENT. NO RETURNED PRODUCT, NO PICTURE OF DEFECT. COMPLAINT CANNOT BE CONFIRMED. CUSTOMER IS USING 2" CONNECTOR WITH NON-AIRLIFE BRANDED CANNULA AND OXYGEN TUBING. NO LOT# PROVIDED, NO FURTHER INVESTIGATION CAN BE CONDUCTED. SALES MANAGER DID NOT HAVE ANY FURTHER INFORMATION WHEN ASKED ON 5/31/2024. MOST LIKELY ROOT CAUSE OF ISSUE IS CUSTOMER IS NOT CONNECTING THE CANNULA AND TUBING PROPERLY. PER (B)(4), ULTIMATE RISK IS CONSIDERED "LOW RISK".

    Description of Event or Problem · 0

    09487 DIFFICULTY CONNECTING EXTENSION CORD AND OXYGEN CANNULA.  REPORT INDICATES DELAY IN CRITICAL THERAPY.

    Description of Event or Problem · 0

    09487 DIFFICULTY CONNECTING EXTENSION CORD AND OXYGEN CANNULA.  REPORT INDICATES DELAY IN CRITICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125959 SUNMED LLC CONNECTOR, TUBING, 2'', DISPOSABLE, PLASTIC CAT SUNMED HOLDINGS LLC S102005 UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other