BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX CUFFED BLUE LINE ULTRA SUCTIONAID

    MDR report key: 8115191 · Received November 29, 2018

    Report

    Report Number
    3012307300-2018-08454
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 28, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOREIGN: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX CUFFED BLUE LINE ULTRA SUCTIONAID SUCTION CATHETER WOULD NOT PASS THROUGH A PATIENT'S TUBE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957275 PORTEX CUFFED BLUE LINE ULTRA SUCTIONAID TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1