BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK PNEUMOTHORAX SET

    MDR report key: 2021621 · Received March 10, 2011

    Report

    Report Number
    1820334-2011-00139
    Event Type
    Injury
    Date Received
    March 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - TENSION PNEUMO IS NOT LABELED IN THE IFU. DEVICE SEPARATION IS NOT LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CONNECTIVE TUBE CAME APART AT THE FLUID END OF THE CLEAR CONNECTOR, LEAVING THE COOK CATHETER OPEN TO AIR. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2011: THIS OCCURRED THREE TIMES. AFTER THE REP VISITED THE HOSPITAL, THE PROBLEM/COMPLAINT IS ACTUALLY RELATED TO THE INCOMPATIBILITY OF ANOTHER MANUFACTURER'S CONNECTING TUBE, AS THE CUSTOMER STATED THAT THE CLEAR CONNECTIVE TUBING IN THE COOK SET WAS NOT USED OR RELATED TO THE ISSUE. CUSTOMER PREFERRED COOK'S CLEAR CONNECTING TUBE AND THINKS IT WILL SOLVE THIS PROBLEM. SINCE THE COOK HEIMLICH VALVE BECAME SEPARATED FROM A NON-COOK CONNECTING TUBE, WHEN AN RN RECONNECTED THE COOK VALVE, HE/SHE ACCIDENTALLY RECONNECTED AT THE WRONG END, WHICH PREVENTED THE PNEUMO FROM DRAINING AND INSTEAD CAUSED A TENSION PNEUMO FOR THIS PATIENT. THE CUSTOMER DID NOT BLAME THE COOK PRODUCT FOR THIS OCCURRENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1