BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY

    MDR report key: 20495131 · Received October 21, 2024

    Report

    Report Number
    1820334-2024-01383
    Event Type
    Malfunction
    Date Received
    October 21, 2024
    Date of Event
    October 4, 2024
    Report Date
    September 9, 2025
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002589056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: ADDITIONAL COMMON NAME: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION. D2B: ADDITIONAL PRODUCT CODE: DRE. E3: OCCUPATION: VALUE ANALYSIS MANAGER. G4: PMA/510(K) #: K182252. 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 THAT A CATHETER HUB FROM A 'COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY' WAS CRACKED AND LEAKING. THE PATIENT'S CENTRAL LINE WAS NOTED TO BE LEAKING AT THE HUB OF THE BLUE PORT. UPON CLOSER OBSERVATION BY THE STAFF, THE HUB WAS NOTED TO BE CRACKED. WHEN THE CATHETER WAS FLUSHED, "IT WOULD SHOOT WATER OUT OF THE CRACK IN THE HUB" THE CATHETER WAS REMOVED AFTER DISCUSSING WITH THE PROVIDER. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076782 COOK CVC TRIPLE LUMEN POWER-INJECTABLE CENTRAL VENOUS CATHETER TRAY FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC G58905 15623188 00827002589056

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown