BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET

    MDR report key: 7660213 · Received July 3, 2018

    Report

    Report Number
    1820334-2018-01998
    Event Type
    Malfunction
    Date Received
    July 3, 2018
    Date of Event
    May 30, 2018
    Report Date
    July 3, 2018
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    00827002029378
    PMA / PMN Number
    K081113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE LOT NUMBER FOR THIS DEVICE IS UNKNOWN. ADDITIONAL INFORMATION: INITIALLY, THE CUSTOMER REPORTED CLOTS FORMED ON THE CATHETER. ADDITIONAL INFORMATION PROVIDED ON 15-AUG-2018 FROM THE CUSTOMER STATED THE CLOTS WERE SEEN VIA ULTRASOUND ALONG THE OUTSIDE OF THE DEVICE. THE DEVICE WAS REMOVED, THE PATIENT WAS GIVEN ASPIRIN AND A WEEK LATER THE CLOTS WERE ABSENT DURING A FOLLOW-UP ECHOCARDIOGRAPH. THE DEVICE DID NOT MALFUNCTION NOR HAVE POTENTIAL TO CAUSE OF CONTRIBUTE TO PATIENT HARM. THIS INCIDENT DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT. EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH, SERIOUS INJURY OR PRODUCT MALFUNCTION AS THE DEVICE DID NOT MALFUNCTION NOR HAVE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT HARM. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K081113. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET WAS USED DURING A RESEARCH STUDY TO RETRIEVE CEREBRAL VENOUS BLOOD SAMPLES. THE LINE WAS IN PLACE FOR APPROXIMATELY 5 HOURS AND SAMPLES WERE TAKEN EVERY 5-10 MINUTES. THE LINE WAS FLUSHED FREQUENTLY WITH SALINE AFTER SAMPLES WERE TAKEN. SIGNIFICANT CLOTS WITHIN THE INTERNAL JUGULAR VEIN WERE OBSERVED AND MEASURED VIA DUPLEX ULTRASOUND. THE PROGRESSION OF THESE CLOTS WERE TRACKED AND SAID TO DISSIPATE. AS REPORTED, THE ISSUE OF CLOTTING WAS NOT NOTED WHEN DIFFERENT CATHETERS WERE USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503512 TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET DQY CATHETER, PERCUTANEOUS DQY COOK INC 6835627 00827002029378

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR