BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 20474418 · Received October 17, 2024

    Report

    Report Number
    1820334-2024-01350
    Event Type
    Injury
    Date Received
    October 17, 2024
    Report Date
    August 13, 2025
    Manufacturer
    COOK INC
    Product Code
    JOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT: 01JAN2017 TO 31DEC2019. D4 - POSSIBLE RPN'S: C-UTPTY-1400-WAYNE-112497-IMH; C-UTPT-1400-WAYNE-112497-IMH; C-UTPT-1020-WAYNE-IMH; C-UTPT-1400-WAYNE-IMH. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL, RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A POST MARKET STUDY THAT THE CATHETER FROM A WAYNE PNEUMOTHORAX CATHETER SET OR TRAY WAS MISPLACED. THE DEVICE WAS USED FOR CHEST TUBE INSERTION DUE SECONDARY SPONTANEOUS PNEUMOTHORAX WHICH WAS DIAGNOSED BY X-RAY. ANTITHROMBIC MEDICATION WAS NOT ADJUSTED OR SUSPENDED PRIOR TO PROCEDURE. THE DEVICE WAS SUCCESSFULLY PLACED IN THE RIGHT LATERAL CHEST AT THE BOTTOM OF THE 4TH INTERCOSTAL SPACE. NO IMAGING WAS PERFORMED DURING DEVICE PLACEMENT. PLACEMENT WAS LATER CONFIRMED BY X-RAY AFTER PLACEMENT. THE CHEST TUBE WAS ATTACHED TO CONTINUOUS SUCTION FOR INITIAL DRAINAGE WHICH WAS SUCCESSFULLY ACHIEVED. TWO DAYS AFTER CATHETER PLACEMENT, PERSISTENT PNEUMOTHORAX WAS REPORTED. AS A RESULT, THE DEVICE WAS REMOVED AND REPLACED. IT WAS NOTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, BUT RELATED TO THE STUDY PROCEDURE AS THE CATHETER WAS INSERTED INTO THE LUNG BLEB; THEREFORE, IT FAILED TO RECTIFY THE PNEUMOTHORAX LEADING TO A LUNG COLLAPSE. NO OTHER ADVERSE EFFECTS WERE REPORTED. THE PATIENT WAS DISCHARGED ON DAY FIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1276803 UNKNOWN JOL CATHETER AND TIP, SUCTION JOL COOK INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Male Required Intervention