BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACHGUARD

    MDR report key: 20306486 · Received September 25, 2024

    Report

    Report Number
    2938401-2024-00004
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    July 20, 2024
    Report Date
    September 25, 2024
    Manufacturer
    B&B MEDICAL TECHNOLOGIES
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    BY DESIGN, THE TRACHGUARD PRODUCT IS CONSTRUCTED OF HYPOALLERGENIC, LATEX-FREE MATERIALS FOR THE SENSITIVE CONDITIONS OF THE USER POPULATION. THE COMPANY CONFIRMED THAT THE PRODUCT WOULD NOT HAVE COME INTO CONTACT WITH ANY LATEX PRIOR TO OR DURING THE MANUFACTURING PROCESS. IT WAS UNKNOWN WHAT OTHER DEVICES WERE USED IN CONJUNCTION WITH THE TRACHGUARD OR HOW THE PRODUCT WAS HANDLED PRIOR TO APPLICATION. IT IS POSSIBLE THAT THERE MAY HAVE BEEN SOME OTHER UNKNOWN UNDERLYING HEALTH ISSUE GIVEN THE ALLERGENIC CONDITION OF THIS PARTICULAR PATIENT. THE DEVICE WAS NOT AVAILABLE FOR REVIEW NOR WERE THERE ANY PHOTOS AVAILABLE. THERE WERE NO NON-CONFORMING MATERIAL REPORTS OR TEMPORARY DEVIATIONS FOUND IN THE DEVICE HISTORY RECORDS FOR P/N:11250 LOT # N2F2201. REJECTION RATES DURING IN PROCESS INSPECTIONS WERE AT ACCEPTABLE LEVELS AND THE DEVICES WERE MANUFACTURED TO THEIR SPECIFICATIONS, IN ACCORDANCE WITH THE PRODUCT DEVICE MASTER RECORD, AND WITH THE APPROPRIATE REVISIONS OF THE PRODUCT LABELING AND INSTRUCTIONS FOR USE. THERE WAS NO EVIDENCE FOUND WITHIN THE COMPANY COMPLAINT FILES OF ANY PAST SKIN IRRITATION ISSUES CAUSED BY THE TRACHGUARD. WITHIN THE LAST 10 YEARS THE PRODUCT HAS RECEIVED A < (B)(4) COMPLAINT RATE, DEEMING THE PRODUCTS TO BE STATISTICALLY SAFE AND LOW RISK. A REVIEW OF THE PRODUCT RISK MANAGEMENT ACTIVITIES CONCLUDED THAT SKIN IRRITANCY HAZARD RISKS RELATED TO THE TRACHGUARD HAVE BEEN REDUCED TO ACCEPTABLE LEVELS USING INSTRUCTIONS FOR USE AND DESIGN CONTROL MEASURES. NO CORRECTIVE OR PREVENTIVE ACTIONS REQUIRED. THE RESULTS OF THIS INVESTIGATION WILL BE FILED WITHIN THE B&B MEDICAL TECHNOLOGIES INTERNAL COMPLAINT FILES FOR STATISTICAL USE. THIS COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT AND THE FILE WILL BE CLOSED.

    Description of Event or Problem · 0

    THE PATIENT WAS WEARING A TRACH TIE FROM HOME THAT WAS WET AND REPLACED IT WITH THE TRACHGUARD, WHICH WAS A DIFFERENT BRAND FROM THE ORIGINAL TRACH TIE THAT WAS APPLIED. THE PATIENT CAUTIONED THAT THEY WERE VERY ALLERGIC TO LATEX AND DIDN'T WANT TO TRY A NEW BRAND. WRITER CHECKED PRODUCT LABEL WHICH SAID NO LATEX. WITHIN APPROXIMATELY 2 MINUTES THE PATIENT HAD EXTENSIVE RASH AROUND NECK WHERE TIES WERE, REQUIRING IMMEDIATE REMOVAL AND MEDICATION. UPON DISCUSSION ASKED PATIENT IF THERE ARE OTHER TYPES OF FIBERS ALLERGIC TO AND SAID ONLY SOMEWHAT TO WOOL. IT WAS UNCLEAR TO THE COMPLAINANT WHY SUCH IMMEDIATE AND STRONG REACTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243245 TRACHGUARD TRACHEOSTOMY TUBE HOLDER CBH B&B MEDICAL TECHNOLOGIES 11250 N2F2201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Other