BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI-TRACH® II SELDINGER TRACHEOSTOMY KIT

    MDR report key: 5887105 · Received August 18, 2016

    Report

    Report Number
    2183502-2016-01759
    Event Type
    Malfunction
    Date Received
    August 18, 2016
    Report Date
    July 22, 2016
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SMITHS MEDICAL HAS RECEIVED THE SAMPLE DEVICE. A FULL EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN AS THE DEVICE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE. SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ONE SAMPLE OF THE 16F 70 CURVED INTRODUCER WAS RECEIVED FOR INVESTIGATION (PART NUMBER 005/079/065). THE SAMPLE WAS A COMPONENT OF THE REPORTED MINI-TRACH® II SELDINGER TRACHEOSTOMY KIT (PART NUMBER 100/461/000). A REVIEW OF THE DEVICE HISTORY RECORD AND INCOMING INSPECTION DATE WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE RETURNED COMPONENT WAS TESTED PER THE INCOMING INSPECTION CRITERIA. THE COMPONENT DID NOT PASS FUNCTIONAL TESTING. INVESTIGATION WAS NOT ABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED DETACHMENT. (B)(4).

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED THAT IMMEDIATELY UPON USE WITH THE PATIENT, THE CUSTOMER FOUND THE DILATOR CONNECTOR DETACHED FROM THE BLUE DILATOR. THE PATIENT IS VENTILATOR DEPENDENT. NO PATIENT OR CLINICAL INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537728 MINI-TRACH® II SELDINGER TRACHEOSTOMY KIT TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO

    Patients

    Seq Age Sex Outcome Treatment
    1