BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASK TRACH ADULT DISP 50/CS

    MDR report key: 2446353 · Received February 10, 2012

    Report

    Report Number
    2050001-2012-00018
    Event Type
    Injury
    Date Received
    February 10, 2012
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BYG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 2 AS TWO PATIENTS WERE REPORTED. NO LOT NUMBER WAS PROVIDED AND THERE WAS NO SAMPLE AVAILABLE FOR EVALUATION. THERE IS NO TREND IDENTIFIED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE SUPPLIER: WE CONFIRM THAT WE DID NOT CHANGE THE WORKING PROCESS, AND EACH PROCEDURE IS IN ACCORDANCE WITH THE ENGINEERING FLOW SHEET AND WORKING GUIDANCE. AS TO THE MOLD, WE CONFIRM WE NEVER CHANGED THE MOLD AND MOLDING CONDITIONS HAVE NOT CHANGED. BELOW IS THE SIZE FOR ALL THE CAVITIES OF THE MOLD. WITH REGARD TO THE STRAP SUPPLIER, WE GET THEIR CONFIRMATION THAT THEY DID NOT CHANGE MANUFACTURING PROCESS, QUALITY AND MATERIAL OF THE STRAP. WE DID PULL-OUT TESTS TO ALL THE LOT SAMPLES DATING FROM (B)(4) 2009. WE COULD SEE FROM THE DATA SHEET AND ILLUSTRATING DIAGRAM, THE GREEN STRAP DETERIORATES A LITTLE, BUT THIS DOES NOT AFFECT ITS FUNCTION. (B)(4). A RETROSPECTIVE REVIEW OF ALL COMPLAINTS DURING THIS TIMEFRAME WAS CONDUCTED BY THE NEW CAREFUSION CUSTOMER ADVOCACY CLINICAL TEAM IN ACCORDANCE WITH INTERNAL STANDARD OPERATING PROCEDURES AND IT WAS DETERMINED THAT THIS EVENT NECESSITATES SUBMISSION AS A MEDICAL DEVICE REPORTABLE (MDR) IN ACCORDANCE WITH 21 CODE OF FEDERAL REGULATION (CFR) PART 803.

    Description of Event or Problem · 1

    PATIENT LOOSENED STRAP ON TRACH MASK, BUT NOT ABLE TO RE-TIGHTEN. TRACH MASK DRAPED OVER TRACH TUBE AND BLOCKED OFF OPENING FOR SHORT PERIOD OF TIME. CLARIFICATION FROM THE SALES REPRESENTATIVE: THE FACILITY REPORTED 2 IDENTICAL INCIDENTS WITH 1 MALE AND 1 FEMALE PATIENT. (B)(6), RESPIRATORY THERAPIST DIRECTOR INDICATED THAT THE CLINICIAN LOOSENED THE TRACH MASK. THE MASK COULD BE TIGHTENED BUT LATER THE TRACH MASK SOMEHOW GOT TWISTED AND THE SOFT PLASTIC PART OF THE MASK SETTLED RIGHT UP AGAINST THE TRACHEOSTOMY TUBE CONNECTOR OCCLUDING IT, NOT ALLOWING THE PATIENT TO BREATHE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASK TRACH ADULT DISP 50/CS MASK, OXYGEN BYG CAREFUSION 001225-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other