BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® ULTRAPERC® SINGLE DILATOR TUBE

    MDR report key: 9205339 · Received October 17, 2019

    Report

    Report Number
    3012307300-2019-05693
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    August 30, 2019
    Report Date
    December 18, 2019
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    JOH
    UDI-DI
    15019315059537
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE CANNULA TO A SMITHS MEDICAL PORTEX® ULTRAPERC® SINGLE DILATOR TUBE IS OBSERVED TO HAVE LITTLE FUNCTIONALITY, IS WEAK AND THAT THE DIAMETER IS VERY SMALL. THE SLEEVE WAS REPORTED TO BE REMOVED TO MAINTAIN A PERMEABLE ROUTE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997130 PORTEX® ULTRAPERC® SINGLE DILATOR TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD; INC. 3775372 15019315059537

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening| R