BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX GENERAL ANESTHESIA CIRCUIT

    MDR report key: 8401517 · Received March 7, 2019

    Report

    Report Number
    3012307300-2019-01275
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    October 19, 2018
    Report Date
    March 7, 2019
    Product Code
    CAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: LOT CONTAINS THE FOLLOWING POSSIBLE NUMBERS: 180528. (B)(6). DEVICE EVALUATION: ONE BREATHING CIRCUIT WAS RECEIVED FOR INVESTIGATION. THE SAMPLE WAS RECEIVED IN USED CONDITION WITHOUT ITS ORIGINAL PACKAGING. IMMEDIATE VISUAL INSPECTION DETECTED A HOLE IN THE PRODUCT. A LEAK FUNCTIONAL TEST WAS COMPLETED AND THE DEVICE DID NOT PASS. IN ADDITION, LEAK TESTS WERE AUDITED IN ORDER TO VERIFY THAT ALL COMPONENTS WERE FREE OF DAMAGE OR DEFECTS. THIRTY TWO (32) UNITS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND. A REVIEW OF THE MANUFACTURING PROCESS WAS ALSO CONDUCTED AND WAS CONSIDERED ADEQUATE AND CORRECT. BASED ON THE EVIDENCE AND TESTING, THE COMPLAINT ALLEGATION WAS CONFIRMED. THE ROOT CAUSE WAS LISTED AS UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX GENERAL ANESTHESIA CIRCUIT HAD A SMALL PINHOLE LEAK WHILE IN USE. THE ISSUE WAS DISCOVERED AFTER HEARING AN AIR LEAK SOUND AND IT WAS REPORTED THEY WERE ABLE TO COVER THE PINHOLE WITH TAPE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192646 PORTEX GENERAL ANESTHESIA CIRCUIT CIRCULATOR, BREATHING-CIRCUIT CAG

    Patients

    Seq Age Sex Outcome Treatment
    1