BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 12668821 · Received October 20, 2021

    Report

    Report Number
    3000219639-2021-00025
    Event Type
    Injury
    Date Received
    October 20, 2021
    Date of Event
    September 20, 2021
    Report Date
    October 20, 2021
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IRRITATION/SORES CAN BE MANIFESTED BY ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER LABS RESPIRATORY CARE PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES 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 COMPLAINT HISTORY FOR THIS PART NUMBER SHOWED FIVE SIMILAR COMPLAINTS IN THE LAST TWO YEARS. THIS IS STILL REASONABLY LOW BASED WHEN CONSIDERING THE CPM METRIC, HOWEVER THIS ISSUE DOES APPEAR TO BE TRENDING UPWARDS. THIS ISSUE WILL BE DISCUSSED AT THE NEXT CARB MEETING FOR DETERMINATION OF NEXT STEPS. THERE IS CURRENTLY A GLOBAL SHORTAGE OF DINCH PLASTICIZER USED IN THESE CANNULAS. TO MEET DEMAND, SOME OF PRODUCTION IS USING THE DOTP PLASTICIZER (WESTMED FORMULATION). THIS FORMULATION IS VALIDATED AND SHOULD PERFORM IDENTICALLY TO THE DINCH FORMULATION. THIS PATIENT MAY HAVE A PARTICULAR SENSITIVITY TO THE DOTP PLASTICIZER. THE 16SOFT SERIES OF CANNULAS FEATURES A SOFTER FACEPIECE AND HEADSET TUBING TO IMPROVE PATIENT COMFORT. IN ORDER TO CREATE THE SOFTER PLASTIC USED IN THESE COMPONENTS, A HIGHER PERCENTAGE OF PLASTICIZER MUST BE USED IN THE RESINS. PATIENTS WITH SENSITIVITY TO PLASTICIZERS MAY BENEFIT FROM CHOOSING A CANNULA THAT USES LESS PLASTICIZER, SUCH AS THE 1600 SERIES OF CANNULAS. 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 UPWARD TREND EMERGING, THIS ISSUE WILL BE DISCUSSED AT THE NEXT CARB MEETING.

    Description of Event or Problem · 0

    CUSTOMER HAD AN ALLERGIC REACTION BURN LIKE MARKS ON PATIENTS NECK AND AROUND EARS.

    Additional Manufacturer Narrative · 1

    IRRITATION/SORES CAN BE MANIFESTED BY ITCHING, REDNESS, RASH OR IN EXTREME CASES, OPEN SORES. THE SALTER LABS RESPIRATORY CARE PRODUCTS ARE GENERALLY MADE FROM PLASTIC/PVC, WHICH HAS A GOOD SAFETY PROFILE FOR IRRITATION AND SENSITIVITY. A PLASTIC PRODUCT MAY CAUSE IRRITATION/SORES 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.

    Description of Event or Problem · 1

    CUSTOMER HAD AN ALLERGIC REACTION BURN LIKE MARKS ON PATIENTS NECK AND AROUND EARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567158 SALTER LABS CANNULA, ADULT, OXYGEN W/3-CHANNEL TUBE 7'(SOFT) CAT 16SOFT-7 10(210405F)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other