BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT MASK INTUBATION ADAPTER

    MDR report key: 171750 · Received June 8, 1998

    Report

    Report Number
    1423507-1998-00181
    Event Type
    Malfunction
    Date Received
    June 8, 1998
    Report Date
    June 8, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    5/13/1998 UNFORTUNATELY WITHOUT SAMPLES, CUSTOMER REPORT COULD NOT BE CONFIRMED. HOWEVER, IF SAMPLES BECOME AVAILABLE, WE WILL BE GLAD TO REOPEN THIS INVESTIGATION. 6/3/1998 SAMPLE WAS RECEIVED OPENED AND WAS INSPECTED VISUALLY. SAMPLE IS OCCLUDED MIDWAY BETWEEN TWO ENDS. CUSTOMER REPORT WAS CONFIRMED. CORRECTIVE ACTION WAS IMPLEMENTED. SUPPLIER MADE MODIFICATION TO MOLD IN 10/1997. SINCE LOT NUMBER CANNOT BE IDENTIFIED, IT IS NOT POSSIBLE TO VERIFY IF PRODUCT RELATED TO COMPLAINT WAS MFG AFTER CORRECTIVE ACTION WAS IMPLEMENTED. 11/18/1998 SAMPLE WAS RECEIVED AND WE INSPECTED VISUALLY. CUSTOMER REPORT WAS CONFIRMED. SAMPLE WAS FOUND TO BE OCCLUDED MIDWAY BETWEEN TWO ENDS. CORRECTIVE ACTIONS HAVE BEEN INITIATED BOTH BY OUR FACILITY, AS WELL AS MFG FACILITY WHERE THIS PRODUCT IS MOLDED TO ADDRESS COMPLAINT. MFG FACILITY LAUNCHED AN INTENSIVE INVESTIGATION INTO THIS MATTER AND HAS IDENTIFIED ROOT CAUSE RESPONSIBLE FOR THIS TYPE OF REPORT. IN ADDITION, ALLEGIANCE HEALTHCARE CORP INITIATED A VOLUNTARY RECALL OF ALL PRODUCT POTENTIALLY AFFECTED BY THIS ROOT CAUSE AND HAS NOTIFIED FDA OF THIS ACTION. ADDITIONAL CORRECTIVE ACTIONS, AT MFG FACILITY, HAVE ALSO BEEN INITIATED AND WERE IMPLEMENTED IN SEPTEMBER OF 1998.

    Description of Event or Problem · 1

    ACCOUNT STATES THERE IS AN INNER FILM THAT IS BLOCKING THE ADAPTER. THIS WAS NOTICED AFTER INSTALLATION WHEN THE PT DIDN'T GET AIR OF GAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RT MASK INTUBATION ADAPTER ADAPTER BZA ALLEGIANCE HEALTHCARE 001820 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other