BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT

    MDR report key: 9188258 · Received October 14, 2019

    Report

    Report Number
    3012307300-2019-05544
    Event Type
    Injury
    Date Received
    October 14, 2019
    Date of Event
    September 12, 2019
    Report Date
    December 18, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING GENERAL ADDITIONAL INFORMATION WAS PROVIDED BY THE COBO MEDICAL SAS REPORTER REGARDING ALL TEN REPORTED COMPLAINTS: CC-0053061-MFR 3012307300-2019-05691, CC-0053069-MFR 3012307300-2019-05692, CC-0053073-MFR 3012307300-2019-05693, CC-0053074-MFR 3012307300-2019-05694, CC-0053104-MFR 3012307300-2019-05560, CC-0053107-MFR 3012307300-2019-05543, CC-0053174-MFR 3012307300-2019-05544, CC-0053176-MFR 3012307300-2019-05545, CC-0053177-MFR 3012307300-2019-05547, CC-0053179-MFR 3012307300-2019-05548. THE REPORTER STATED "THE SHIRT GETS REMOVED TO ADEQUATELY AND APPROPRIATELY CLEAN THE PATIENT, WHEN A SHIRT IS REMOVED IT CANNOT BE INTRODUCED AGAIN BECAUSE THE SPACE IS TOO SMALL. IN WHICH IT GETS LEFT OUT NOT DUE TO PATIENT SAFETY SINCE THIS KIT HAS ALL THE PARTS". THEY ALSO STATED A SHIRT WAS REMOVED BECAUSE "THE PATIENTS HAD PROBLEMS BREATHING AS THE BRONCHIAL PATHWAY IS VERY SMALL." FURTHERMORE, THE REPORTER INDICATED THAT THE EVENT HAS LED TO AN INCREASE IN "TRACHEITIS" FOR THEIR PATIENTS. ADDITIONALLY, THE REPORTER NOTED IT WAS NECESSARY TO COMPLETE A TUBE CHANGE OUT "VARIOUS TIMES". HOWEVER, THEY COULD NOT CONFIRM HOW MANY OCCURRENCES THIS INTERVENTION WAS REQUIRED. THEREFORE, ALL TEN RELATED FILES WILL BE CONSIDERED AS A SERIOUS INJURY DUE TO THE REPORTED ADVERSE PATIENT EFFECTS AND REQUIRED INTERVENTION.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: FOREIGN COUNTRY: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR WAS IN USE WITH A PATIENT AT THE HOSPITAL. THE REPORTER STATED THE "TQT IS VERY BLAND, SKINNY AND WITH THE SMALL LIGHT IS COVERED EASILY AND REQUIRES REMOVAL OF THE SHIRT (SLEEVE)". IT WAS ALSO REPORTED THAT THE PATIENT HAD "BAD SECRETIONS, POOR SWALLOWING, AND INCREASED BREATHING PATTERNS." NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981324 PORTEX BLUE LINE ULTRA SUCTIONAID PERCUTANEOUS DILATION TRACHEOSTOMY KIT TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3775372

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening| R