BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS

    MDR report key: 15277059 · Received August 23, 2022

    Report

    Report Number
    3012307300-2022-15871
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    January 1, 2020
    Report Date
    August 23, 2022
    Manufacturer
    ST PAUL
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE WAS RECEIVED IN USED CONDITIONS, WITHOUT ITS ORIGINAL PACKAGING. THE SAMPLE DOES NOT HAVE AN ELBOW CONNECTOR. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURER OPERATOR OF DEVICE IS UNKNOWN. NO INFORMATION IS PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10009406, AS A RESULT OF WARNING LETTER CMS# 617147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER OPENING THE DEVICE PACKAGE, THE CUSTOMER NOTICED NO GS ELBOW CONNECTOR CAME WITH THE ANESTHESIA CIRCUIT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830599 PORTEX ANESTHESIA ACCESSORIES AND CONNECTORS TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO ST PAUL 3846762

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown