BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 12084263 · Received June 29, 2021

    Report

    Report Number
    3012307300-2021-06630
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 1, 2021
    Report Date
    May 3, 2023
    Manufacturer
    ST PAUL
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE KIT WAS RETURNED. THE PACKAGE WAS OPEN AND THAT THERE WAS NO FILTER IN THE PACKAGE. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE UNIDENTIFIED. ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE: AS A MEASURE TO PREVENT RECURRENCE, ALL THE WORKERS IN THE RELATED PROCESSES OF OUR MANUFACTURING DEPARTMENT AWARE OF THE DETAILS OF THIS EVENT AND ALERTED THEM.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL BREATHING/PORTEX GENERAL ANESTHESIA CIRCUITS DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED NO HME FILTER WAS PACKED IN THE PRODUCT SET. SO HE DID NOT USE THE PRODUCT SET. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984858 PORTEX BREATHING CIRCUITS BTL ST PAUL 210413

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown