BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 17953798 · Received October 17, 2023

    Report

    Report Number
    1820334-2023-01398
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Report Date
    December 11, 2023
    Manufacturer
    COOK INC
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: UPON FURTHER REVIEW OF THE INFORMATION PROVIDED AND THE RETURNED DEVICE, IT WAS DETERMINED THE DETAILS OF THIS EVENT ARE IDENTICAL TO THE EVENT CAPTURED IN REPORT 1820334-2023-01123. THEREFORE, THIS COMPLAINT WILL BE CANCELED BY THE MANUFACTURER, AND THE COMPLAINT DEVICE WILL BE CAPTURED IN REPORT 1820334-2023-01123.

    Additional Manufacturer Narrative · 0

    D 2A - COMMON NAME: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY. D 2B - PRODUCT CODE: GBO, LJE. E1 - CUSTOMER (PERSON): PHONE: (B)(6), FAX: (B)(6). G4 - PMA/510(K) #: K173035. 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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    AN ADDITIONAL ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS RECEIVED WITH THE COMPLAINT DEVICE REPORTED IN MDR # 1820334-2023-01123. PRELIMINARY ANALYSIS OF THE ADDITIONAL DEVICE NOTED A HOLE IN THE CATHETER SHAFT NEAR THE EDGE OF THE CAP. THE CATHETER FAILED THE LEAK TEST. 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
    93764 ULTRATHANE MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown