BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET

    MDR report key: 3836021 · Received May 12, 2014

    Report

    Report Number
    1820334-2014-00214
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 2014
    Manufacturer
    COOK, INC.
    Product Code
    KCG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER NOT PROVIDED BY THE REPORTER. EXPIRATION DATE UNK AS LOT IS UNK. PERFORATION IS NOT LABELED. TRAUMA TO THE POSTERIOR TRACHEA WALL IS MENTIONED IN THE IFU. EVENT IS NOT REPORTABLE UNDER (B)(4).

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT UNDERWENT TRACHEOSTOMY TUBE PLACEMENT ON (B)(6) 2014. AFTER INITIAL DILATION WITH SMALL DILATOR, WHICH WAS DIFFICULT BUT SUCCESSFUL, THE USER EXCHANGED FOR A BLUE RHINO AND INSERTED 8MM BIVONA TTS. UPON CONFIRMATION IT WAS CLEAR THAT THE STYLET WAS NOT INTRALUMINAL. IT WAS NOTED THAT THERE WAS A RENT IN THE POSTERIOR TRACHEAL WALL. IT IS UNCLEAR AS TO WHEN THE STYLET PERFORATED THE POSTERIOR TRACHEA WALL. PT IS STABLE. TRACHEAL TUBE WAS PASSED BELOW LEVEL OF INJURY. OBSERVING FOR 1 WEEK FOR HEALING OF PERFORATION. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283382 CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET KCG DILATOR, TRACHEAL KCG COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R