BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® BLUE LINE ULTRA® SUCTIONAID®

    MDR report key: 7997387 · Received October 23, 2018

    Report

    Report Number
    3012307300-2018-01908
    Event Type
    Injury
    Date Received
    October 23, 2018
    Date of Event
    September 24, 2018
    Report Date
    September 27, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION : ONE PORTEX TRACHEOSTOMY SAMPLE WAS RECEIVED IN USED CONDITION WITHOUT ITS ORIGINAL PACKAGING FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND NO DISCREPANCIES WERE FOUND. A LEAK TEST WAS PERFORMED AND A LEAK WAS FOUND IN THE PILOT BALLOON OF THE RETURNED SAMPLE. TO FURTHER INVESTIGATE THE ISSUE, RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE. FURTHERMORE, FLOW TESTS WERE AUDITED DURING THIRTY TWO (32) UNITS AND THE FOLLOWING WAS DETECTED IN THE STAMPING MACHINE: IT WAS OBSERVED THAT THE PAD OF THE MACHINE HAS MOVEMENT, IS NOT FULLY STABLE AND THE PILOT BALLOON IS RAISED FROM THE VALVE AREA, AND BECAUSE THE PILOT BALLOON DOES NOT ENTER COMPLETELY IN THE FIXTURE, THIS MAY CAUSE OR CONTRIBUTE TO THE VALVE TO TOUCH THE PAD AND CAUSE A TEAR. BASED ON THE EVIDENCE AND TESTING, THE COMPLAINT WAS CONFIRMED. THE PROBLEM SOURCE CAN BE TRACED TO MANUFACTURING, WITH THE MOST PROBABLE CAUSES RELATED TO EITHER OF THE FOLLOWING: THE MACHINE PAD MOVEMENT, THE PILOT BALLOON BEING RAISED FROM THE VALVE AREA, OR A LACK OF DETECTION BY PRODUCTION PERSONNEL.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT 9 HOURS AFTER REPLACING A SMITHS MEDICAL TRACHEOSTOMY, ITS PILOT BALLOON WOULD NOT INFLATE. CUSTOMER THEN FILLED THE PILOT BALLOON WITH AIR, BUT IT WOULD NOT INFLATE YET AGAIN, SO THEY REPLACED THE PRODUCT STILL ANOTHER ONE. NO PATIENT INJURY. RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837237 PORTEX® BLUE LINE ULTRA® SUCTIONAID® TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R