BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX GENERAL ANESTHESIA CIRCUITS

    MDR report key: 13388667 · Received January 28, 2022

    Report

    Report Number
    3012307300-2022-02117
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 9, 2022
    Manufacturer
    NULL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. ONE UNIT WAS RETURNED FOR EVALUATION OF THE FAILURE AND PICTURES BY THE CUSTOMER WERE PROVIDED. UNIT RETURNED WAS RECEIVED INSIDE OF A PLASTIC BAG WHICH IS NOT THE ORIGINAL PACKAGE. SAMPLE WAS RECEIVED TORN, TO DETERMINE THE CONFIRMATION OF THE COMPLAINT, SEE THE COMPLETE INVESTIGATION AND THE ROOT CAUSE SECTION. AS PART OF THE INVESTIGATION, 20 SAMPLES WERE TAKEN TO SEE THERE IS ANY CONDITION COULD CAUSE TORN BREATHING BAGS: SHARP EDGES ON BINDER?S WORKSTATION: THE TEST CONSISTED TO EVALUATE IF THE CONDITION OF THE BINDERS OF THE PROCESS CAN BE DAMAGE / BROKE THE BREATHING BAGS PACKAGING TEST: THE TEST CONSISTED TO EVALUATE IN THIS PROCESS IF THE UNIT CAN BE DAMAGE DUE STUCK. CONCLUSION: IT IS CONCLUDED THAT FAILURE REPORTED COULD NOT BE REPRODUCED IN THE MANUFACTURING PROCESS ACCORDING TO THE ANALYSIS MENTIONED ABOVE. ROOT CAUSE CANNOT BE ASSOCIATED WITH THE MANUFACTURING PROCESS SINCE THE FAILURE REPORTED COULD NOT BE REPRODUCED USING THE TOOLS FROM ASSEMBLY AND PACKAGING PROCESS. THEREFORE THE DAMAGE (BROKEN) WAS AFTER THE PRODUCT LEFT SHM FACILITIES. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. LOTS 4190255 WAS MANUFACTURED WITH (B)(4) UNITS; LOTS MET THE REQUIREMENTS TO RELEASE WITH NO DEVIATIONS IDENTIFIED DURING THEIR MANUFACTURED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PRE-USE CHECK, A HOLE OR TEAR WAS FOUND IN THE BREATHING BAG. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1641948 PORTEX GENERAL ANESTHESIA CIRCUITS TUBE, TRACHEAL (W/WO CONNECTOR) BTR 4190255

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown