BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT

    MDR report key: 8318009 · Received February 7, 2019

    Report

    Report Number
    3012307300-2019-00637
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 8, 2019
    Report Date
    April 12, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    OFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TRACHEOSTOMY WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND IT TO BE IN GOOD CONDITION. NO CRACK ON THE SUCTION LINE WAS VISIBLE. THEN A SYRINGE WAS INSERTED INTO BLUE HUB AND REPORTED SPLIT WAS OBSERVED (SEE PHOTO OF DEFECT). SUCTION CONNECTOR IS CLEARLY BROKEN (ACROSS ITS LENGTH) WHICH IS RESULTING TO LEAK BETWEEN SYRINGE AND CONNECTOR CONNECTION. THIS CONFIRMS THE REPORTED CUSTOMER COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE TO THE REPORTED ISSUE COULD BE DETERMINED, THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A ROOT CAUSE RELATED TO MANUFACTURING.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT HAD A CRACK ON THE BLUE CONNECT TIP OF THE SUCTION PORT. THIS WAS NOTED WHILE CONNECTING THE LUER LOCK 10ML SYRINGE, RESULTING IN EXCESS MOISTURE ON THE SITE, CAUSING DISCOMFORT TO THE PATIENT. NO PATIENT INJURY OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112006 BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT TRACHEOBRONCHIAL SUCTION CATHETER KIT OFR SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening