BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 9176777 · Received October 10, 2019

    Report

    Report Number
    1820334-2019-02558
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    September 30, 2019
    Report Date
    March 4, 2020
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002500037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED 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 AND/OR PRODUCT MALFUNCTION. 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, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR 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

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

    Additional Manufacturer Narrative · 1

    PER THE INITIAL REPORTER, THE DEVICE WILL NOT BE RETURNED. OCCUPATION: UNKNOWN. PMA/510(K) NUMBER: K160884. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, WHILE FLUSHING THE DEVICE, PRIOR TO PATIENT CONTACT FOR AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER WAS FOUND TO BE BENT. ADDITIONAL INFORMATION PROVIDED 03 OCT 2019 REVEALED THAT THE DEVICE WAS FOUND TO HAVE SHARP EDGES AT THE KINK / BEND "BECAUSE IT WAS SO COMPLETELY CRUSHED". PER THE USER, THE PACKAGING OF THE DEVICE WAS FINE; HOWEVER, IT LOOKED LIKE THE FRONT FIVE OR SIX INCHES OF THE DEVICE WOULD "SNAP OFF". A NEW DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969107 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G50003 9788473 00827002500037

    Patients

    Seq Age Sex Outcome Treatment
    1