BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAHURKAR

    MDR report key: 8731689 · Received June 25, 2019

    Report

    Report Number
    1317749-2019-00001
    Event Type
    Injury
    Date Received
    June 25, 2019
    Report Date
    June 25, 2019
    Manufacturer
    KENDALL COMPANY ARGYLE PLANT
    Product Code
    NIE
    PMA / PMN Number
    K000087
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, THE COMPLAINT SAMPLE WAS RECEIVED. AN UNOPENED 12FR. MAHURKAR TRIPLE LUMEN CURVED EXTENSION TRAY, 16CM, PRODUCT CODE (B)(4), (B)(6) LOT NUMBER 913691 WAS RETURNED AT THE MANUFACTURING SITE FOR REVIEW. A SLICE OF THE CATHETER WAS EXAMINED MICROSCOPICALLY AND FOUND TO BE WITHIN SPECIFICATIONS. THIS COMPLAINT HAS NOT BEEN CONFIRMED. THE CATHETER PROFILE WAS FOUND TO BE WITHIN SPECIFICATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THEY INSERTED A 16CM CATHETER INTO RIGHT IJ VEIN, AND LOADED WITH 1.5ML HEPARIN PER IFU. POSTOPERATIVELY, THE PATIENT'S PTT ROSE TO GREATER THAN 240 AND THE PATIENT DEVELOPED A HEMATOMA. TESTING OF PRIMING VOLUME ON UNUSED CATHETERS FROM SAME LOT SHOWED ACTUAL FILL VOLUME OF 1.0-1.1, COMPARED WITH RECOMMENDED 1.5 IN IFU. OF NOTE, FILL VOLUME FOR 16CM CATHETER LISTED AS SAME AS FOR 19.5CM CATHETER, BOTH 11.5 FR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526369 MAHURKAR CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED NIE KENDALL COMPANY ARGYLE PLANT 8888101002 913691

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention