BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ANESTHESIA EXPANDABLE BREATHING CIRCUIT

    MDR report key: 19058810 · Received April 8, 2024

    Report

    Report Number
    3012307300-2024-02250
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 1, 2024
    Report Date
    May 15, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    OFP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL PACKAGE. FIVE PHOTOS WERE INCLUDED FOR EVALUATION; HOLE IN THE BAG WAS OBSERVED. PER VISUAL INSPECTION, A HOLE WAS DETECTED IN THE BAG. THE COMPLAINT WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS. THIS ISSUE WILL CONTINUE TO BE MONITORED AND FURTHER ACTIONS TAKEN ACCORDINGLY TO DETERMINE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    NO INFORMATION HAS BEEN PROVIDED TO DATE. D4 - EXPIRATION DATE AND H4 - MANUFACTURE DATE ARE BASED ON THE RETURNED COMPONENT ITEM AND LOT NUMBER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED AN "AIR LEAK FROM THE ANESTHESIA BAG". THE EVENT OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. THE EVENT OCCURRED IN THE USER FACILITY. THE REPORTED ITEM NUMBER WAS CA13B0/400/000JP AND LOT NUMBER 240208. THE CUSTOMER ONLY RETURNED A COMPONENT (THE BREATHING BAG) OF THAT REPORTED ITEM BREATHING CIRCUIT. THE RETURNED ITEM NUMBER IS 67003---802 AND THE RETURNED ITEM LOT NUMBER 4442735.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136150 PORTEX ANESTHESIA EXPANDABLE BREATHING CIRCUIT ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) OFP SMITHS MEDICAL ASD, INC. 240208

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown