BEUDAMED
    FDA Adverse Event Other Summary report: N

    0600634 10 F LEONARD CATHETER

    MDR report key: 6282837 · Received January 25, 2017

    Report

    Report Number
    MW5067505
    Event Type
    Other
    Date Received
    January 25, 2017
    Date of Event
    November 2, 2016
    Report Date
    January 4, 2017
    Manufacturer
    BARD PERIPHERAL VASCULAR/BARD ACCESS SYSTEM
    Product Code
    DQO
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016 4W RN WENT TO FLUSH THE GROSHONG CATHETER AND BLOODY FLUID STARTED TO SPURT OUT OF THE PIG TAIL. THE RN INSPECTED THE CATHETER AND THERE WAS A 1/4 INCH SLIT IN THE PIGTAIL. THE CATHETER REFERENCE #0600634. A PRODUCT COMPLAINT WAS COMPLETED AND SUBMITTED TO BARD ACCESS SYSTEMS. (B)(4). UNKNOWN DATE OF INSERTION. PRODUCT DISCARDED. SECOND INCIDENT OCCURED ON (B)(6) 2016. AN 4W RN WENT TO FLUSH THE RED CAPPED PORT OF THE GROSHONG CATHETER AND THERE WAS A SMALL HOLE IN THE CATHETER JUST BELOW THE LARGER PART OF THE LUMEN OF THE PIGTAIL. THE GROSHONG CATHETER WAS INSERTED (B)(6) 2016. THE PATIENT REQUIRED INTERVENTIONAL RADIOLOGY TO REPLACE THE GROSHONG CATHETER. A PRODUCT COMPLAINT WAS REPORTED AND LOGGED UNDER (B)(4). THE MANUFACTURE REQUESTED RETURN OF THE PRODUCT. THE PRODUCT WILL BE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60944 0600634 10 F LEONARD CATHETER GROSHONG CATHETER SHORT TERM DQO BARD PERIPHERAL VASCULAR/BARD ACCESS SYSTEM
    60945 10 F LOENARD CATHETER GROSHONG CATHETER SHORT TERM DQO BARD PERIPHERAL VASCULAR/BARD ACCESS SYSTEM 0600634

    Patients

    Seq Age Sex Outcome Treatment
    1 Other