BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAYNE PNEUMOTHORAX SET

    MDR report key: 3815578 · Received May 7, 2014

    Report

    Report Number
    1820334-2014-00207
    Event Type
    Injury
    Date Received
    May 7, 2014
    Report Date
    April 17, 2014
    Manufacturer
    COOK, INC.
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(4) 2014 COOK REP WAS CONTACTED BY ACTING NURSE MANAGER REGARDING EQUIPMENT IN ICU. IT WAS STATED THAT THE LAST WEEK THE WAYNE PNEUMOTHORAX SET PRODUCT WAS BEING INSERTED BY A REGISTRAR WHO WAS BEING SUPERVISED BY AN EXPERIENCED DOCTOR. NEAR THE END OF THE PROCEDURE, THE EXPERIENCED DOCTOR WAS CALLED OUT FOR A PHONE CALL, SO THE END OF THE PROCEDURE WAS NO SUPERVISED. AN HOUR LATER (FOLLOWING THE X-RAY), TI SHOWED THAT THE CATHETER WAS STRAIGHT AND NOT CURLS (PIGTAIL). (THE LACK OF PIGTAIL IN X-RAY WAS DUE TO OBTURATOR BEING LEFT IN). WHEN THEY SAW ON X-RAY THAT THE CATHETER WAS STRAIGHT RATHER THAN CURLED THEY HAD A CLOSER LOOK AT THE PATIENT AND REALIZE DTH OBTURATOR WAS LEFT IN PLACE. THEY THEN REMOVED IT AN THAT WAS IT. NO PROBLEMS CAUSED TO PATIENT AT ALL. EDUCATION WAS GIVEN TO HOSPITAL STAFF. THE PATIENT DID NOT REQUIRE NAY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274851 WAYNE PNEUMOTHORAX SET CANNULA, CATHETER DQR COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other