BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 12610048 · Received October 11, 2021

    Report

    Report Number
    3000219639-2021-00024
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    September 11, 2021
    Report Date
    October 11, 2021
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALLERGIC REACTIONS CAN BE MANIFESTED BY SWELLING, ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER CANNULAS PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES/SWELLING FOR SEVERAL REASONS, INCLUDING, THE DEVICE HAS BEEN CONTAMINATED WITH AN EXTERNAL SUBSTANCE (E.G., MOLD RELEASE AGENT, LOTIONS, MEDICATIONS) WHICH CAUSE IRRITATION/SORES, USING DEVICE FOR TOO LONG (MAY BECOME ROUGH OR BACTERIALLY CONTAMINATED), OR INDIVIDUAL PATIENT-SPECIFIC HYPERSENSITIVITY. IF THE OXYGEN TUBING IS NOT CHANGED OUT ON A REGULAR BASIS OR AS INDICATED ON THE PACKAGING SORES OR IRRITATIONS MAY RESULT. THIS ALLERGIC REACTION CAUSED SLIGHT SWELLING BUT WAS NOT LIFE THREATENING. REFERENCE DOCUMENT REF-10015 ADDRESSES THE FAILURE MODE AND RISKS ASSOCIATED WITH THE TYPE OF COMPLAINT. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET. COMPLAINT HISTORY FOR THIS PART NUMBER WAS REVIEWED FOR THE LAST 24 MONTHS. NINE SIMILAR COMPLAINTS HAVE BEEN REPORTED. THIS ISSUE WILL BE BROUGHT TO CARB FOR INVESTIGATION AND DETERMINATION OF NEXT STEPS. THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS PLASTICIZER LEACHING, AS WELL AS PATIENTS WHO ARE ESPECIALLY SENSITIVE TO PLASTICIZER. FURTHER INVESTIGATION IS NEEDED. INITIAL INVESTIGATION FINDINGS SHOW THAT A NEW TYPE OF PLASTICIZER (DOTP) IS BEING USED INSTEAD OF THE TRADITIONAL DINCH PLASTICIZER. THIS IS DUE TO A GLOBAL SHORTAGE OF DINCH. THE DOTP FORMULATION HAS BEEN VALIDATED. HOWEVER, BASED ON THE INCREASE IN THESE TYPES OF COMPLAINTS, ADDITIONAL CYTOTOXICITY TESTING MIGHT NEED TO BE PERFORMED. RA: THIS FAILURE MODE (R3) SKIN IRRITATION DUE TO EXPOSURE TO A SKIN IRRITANT, IS IDENTIFIED ON THE RISK ANALYSIS FILE (RMA-20017A) FOR OXYGEN CANNULAS. THE SEVERITY OF HARM ASSOCIATED WITH THIS FAILURE MODE IS CONSIDERED AN EXTREME (7) RISK AND DOES NOT MEET THE RISK THRESHOLD FOR CARB REVIEW (8). HOWEVER, BASED ON THE INCREASED INCIDENCE OF THIS ISSUE, THIS ISSUE WILL BE DISCUSSED AT THE NEXT CARB MEETING.

    Description of Event or Problem · 0

    ALLERGIC REACTION/SWELLING NASAL PASSAGES.

    Additional Manufacturer Narrative · 1

    ALLERGIC REACTIONS CAN BE MANIFESTED BY SWELLING, ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER CANNULAS PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES/SWELLING FOR SEVERAL REASONS, INCLUDING, THE DEVICE HAS BEEN CONTAMINATED WITH AN EXTERNAL SUBSTANCE (E.G., MOLD RELEASE AGENT, LOTIONS, MEDICATIONS) WHICH CAUSE IRRITATION/SORES, USING DEVICE FOR TOO LONG (MAY BECOME ROUGH OR BACTERIALLY CONTAMINATED), OR INDIVIDUAL PATIENT-SPECIFIC HYPERSENSITIVITY. IF THE OXYGEN TUBING IS NOT CHANGED OUT ON A REGULAR BASIS OR AS INDICATED ON THE PACKAGING SORES OR IRRITATIONS MAY RESULT. THIS ALLERGIC REACTION CAUSED SLIGHT SWELLING BUT WAS NOT LIFE THREATENING. REFERENCE DOCUMENT (B)(4) ADDRESSES THE FAILURE MODE AND RISKS ASSOCIATED WITH THE TYPE OF COMPLAINT. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Description of Event or Problem · 1

    ALLERGIC REACTION/SWELLING NASAL PASSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508845 SALTER LABS CANNULA, ADULT, OXYGEN W/3-CHANNEL TUBE 7'(SOFT) CAT 16SOFT-7

    Patients

    Seq Age Sex Outcome Treatment
    1 Other