BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER

    MDR report key: 20464539 · Received October 16, 2024

    Report

    Report Number
    1820334-2024-01340
    Event Type
    Malfunction
    Date Received
    October 16, 2024
    Date of Event
    October 10, 2024
    Report Date
    November 12, 2024
    Manufacturer
    COOK INC
    Product Code
    FGE
    UDI-DI
    00827002069909
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: ADDITIONAL COMMON NAME: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY; LJE CATHETER, NEPHROSTOMY; LJE CATHETER, NEPHROSTOMY D2B: ADDITIONAL PRODUCT CODE: GBO; LJE. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE. THE DEVICE WAS RECEIVED ON 05NOV2024. UPON INVESTIGATION, IT WAS DISCOVERED THAT ALL THE SEALS WERE PRESENT AND INTACT. HOWEVER, THE PACKING WAS TORN AND DISCOLORED. THERE IS NO EVIDENCE TO SUGGEST THAT THE OBSERVED DEVICE FAILURE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR A SERIOUS INJURY IF THE FAILURE WERE TO RECUR. FURTHERMORE, THERE IS NO EVIDENCE THAT THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY, AS NO LIFE-THREATENING OR PERMANENTLY IMPAIRING INJURY TOOK PLACE, NOR WAS INTERVENTION TAKEN AS A RESULT OF THE DEVICE FAILURE WHICH WOULD BE REQUIRED TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE TO THE PATIENT. AS SUCH, THE EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY, OR REPORTABLE PRODUCT MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER PACKAGING OF AN ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER WAS FOUND TO BE UNSEALED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2558149 ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC G06990 16231464 00827002069909

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown