BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY DISPOSABLE INNER CANNULA & DISPOSABLE CANNULA LOW PRE

    MDR report key: 70494 · Received February 21, 1997

    Report

    Report Number
    2029387-1997-00024
    Event Type
    Injury
    Date Received
    February 21, 1997
    Report Date
    January 22, 1997
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A HOMECARE PT REQUIRED EMERGENCY MEDICAL INTERVENTION WHEN THE SIZE 6 DIC, DISPOSABLE INNER CANNULA OCCLUDED AND VENTILATION WAS COMPROMISED. THE6DIC WAS REPLACED, PT WAS TREATED AND RETURNED TO BASELINE CONDITION. PT REPORTS THAT THE 6DIC WAS IN USE FOR APPROX. TWO TO THREE MONTHS AND HAS REPEATEDLY BEEN CLEANED AND SOAKED IN FULL STRENGTH H2O2. PT ACKNOWLEDGES THAT HE HAS BEEN TOLD BY HIS HEALTH CARE PROVIDERS THAT THE DIC IS INTENDED FOR SINGLE USE AND NOT INTENDED TO BE CLEANED AND REUSED. PT REPORTS THAT DUE TO FINANCIAL CONSTRAINTS HE CANNOT AFFORD TO FOLLOW VERBAL AND PRINTED DEVICE USAGE AND REPLACEMENT INSTRUCTIONS. PT ALSO REPORTS THAT HE HAS RESORTED TO USING DISCARDED DIC'S. PT'S PHYSICIANS AND CASE MANAGERS HAVE BEEN CONTACTED AND INFORMED OF THE REPORTED EVENTS AND CONTRAINDICATED DEVICE USAGE. IN ADDITION, MFR HAS ALSO SHIPPED REPLACEMENT DEVICES TO THE PRIMARY PHYSICIAN FOR THIS PT. THE TRACHEOSTOMY TUBE ADULT HOME CARE MANUAL AND VIDEO WERE ALSO SENT TO THE PT TO REVIEW AND DISCUSS WITH HIS HEALTH CARE PROVIDERS. THERE WAS ONE PT INVOLVED. THE 6DIC DEVICE WILL NOT BE RETURNED TO THE MFR FOR IDENTIFICATION, ANALYSIS AND INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPOSABLE INNER CANNULA & DISPOSABLE CANNULA LOW PRE TRACHEOSTOMY TUBE BTO MALLINCKRODT MEDICAL, INC. 6 DIC/6DCT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention LIFECARE PLV 100 & 102, VARIOUS VENTILATOR ADAPTOR| CONNECTORS (MFR. MODEL TYPES UNK)