BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® DISPOSABLE ANESTHESIA BREATHING CIRCUIT

    MDR report key: 6147438 · Received December 6, 2016

    Report

    Report Number
    3012307300-2016-00459
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 11, 2016
    Report Date
    August 16, 2017
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL LOT NUMBER: 3194024, 3231529, 3231530, 3232362, AND 3232363. SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. (B)(4).

    Additional Manufacturer Narrative · 1

    ONE DEVICE WAS RETURNED FOR EVALUATION WITHOUT ITS ORIGINAL PACKAGING. VISUAL INSPECTION OF THE DEVICE FOUND A TEAR ON THE BAG. FUNCTIONAL TESTING INVOLVED A LEAK TEST, WHICH THE DEVICE FAILED. A REVIEW OF THE TESTING AND INSPECTION DOCUMENTS WAS PERFORMED AND DEEMED ADEQUATE AND CORRECT. A REVIEW OF THE MANUFACTURING PROCESS FOR A SIMILAR PART NUMBER WAS PERFORMED (SAME MANUFACTURING PROCEDURES, PROCESS CONTROLS, AND INSPECTIONS) AND FOUND NO ISSUES. BASED ON THE EVIDENCE, THE MOST PROBABLE ROOT CAUSE WAS ATTRIBUTED TO A SUPPLIER ISSUE; THE BAG WAS RECEIVED DAMAGED FROM THE SUPPLIER AND LEAK TEST DID NOT PROPERLY IDENTIFY THE ISSUE PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PORTEX® DISPOSABLE ANESTHESIA BREATHING CIRCUIT WAS IN USE WITH AN ANESTHESIA MACHINE WHEN A LEAK ALARM OCCURRED. IT WAS OBSERVED THAT THERE WAS A BREAK ON THE UPPER PART OF THE ANESTHESIA BAG. THE DEVICE WAS IN USE FOR ONE MINUTE BEFORE THE ISSUE WAS OBSERVED. NO PATIENT INJURY WAS REPORTED. THE EVENT WAS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799268 PORTEX® DISPOSABLE ANESTHESIA BREATHING CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1