BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT MASK INTUBATION ADAPTER

    MDR report key: 147341 · Received February 3, 1998

    Report

    Report Number
    1423507-1998-00025
    Event Type
    Malfunction
    Date Received
    February 3, 1998
    Date of Event
    December 30, 1997
    Report Date
    February 3, 1998
    Manufacturer
    ALLEGIANCE HEALTHCARE
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    2/16/1998 ALTHOUGH SAMPLE AND LOT NUMBER UNAVAILABLE FOR INVESTIGATION CONDUCTED BY OUR MFG FACILITY, SEVERAL PREVENTIBLE ACTIONS HAVE BEEN IMPLEMENTED TO PREVENT SIMILAR DEFECTIVE PARTS FROM BEING RECEIVED BY OUR CUSTOMERS. THESE INCLUDE NOTIFICATION AND TRAINING OF OUR PACKAGING STAFF RESPONSIBLE FOR THIS PRODUCT. ON-GOING INVESTIGATION IS UNDER WAY TO DETERMINED CAUSE OF BLOCKED AIRWAY. 1/21/1998 OUR CONTINUED INVESTIGATION OF THIS ISSUE HAD DETERMINED CAUSE TO BE RELATED TO PROBLEM WITH MOLD WHICH MANUFACTURERS THIS COMPONENT. SIMILAR DEFECTS HAD BEEN FOUND DURING PRODUCTION RUN. MOLD WAS PULLED FROM SERVICE AND REPAIRS WERE COMPLETED. SIMILAR DEFECTS HAD BEEN FOUND DURING A PRODUCTION RUN. THE MOLD WAS PULLED FROM SERVICE AND REPAIRS WERE COMPLETED. THE PROPER OPERATION OF THE MOLD WAS VERIFIED BEFORE IT WAS RETURNED TO SERVICE. SINCE A LOT NUMBER WAS UNAVAILABLE, IT COULD NOT BE DETERMINED IF THE ADAPTER REPORTED WAS MFG PRIOR TO THE REPAIRS TO THE EQUIPMENT. 11/18/1998 CORRECTIVE ACTIONS HAVE BEEN INITIATED BOTH BY OUR FACILITY, AS WELL AS MFG FACILITY FACILITY WHERE THIS PRODUCT IS MOLDED, TO ADDRESS COMPLAINT. MFG FACILITY LAUNCHED 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 THE FDA OF THIS ACTION. ADDITIONAL CORRECTIVE ACTIONS, AT THE MFG FACILITY, HAVE ALSO BEEN INITIATED AND WERE IMPLEMENTED IN SEPTEMBER OF THIS YEAR.

    Description of Event or Problem · 1

    ACCOUNT STATES CLEAR PLASTIC WAS INSIDE ADAPTER WHICH WOULD CAUSE NO AIR FLOW. "PT NEEDS AIRFLOW TO SURVIVE".

    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 86 YR Other