BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY

    MDR report key: 6777197 · Received August 9, 2017

    Report

    Report Number
    1820334-2017-02198
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 31, 2017
    Report Date
    January 12, 2018
    Manufacturer
    COOK INC
    Product Code
    FOZ
    PMA / PMN Number
    K081113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTED NARRATIVE: THE USER FACILITY HAS INFORMED COOK INC. ON AUG 17, 2017 THAT THE DEVICE REPORTED WAS NOT A COOK PRODUCT. THE DEVICE WAS IDENTIFIED TO BE AN ARROW INTERNATIONAL MULTI-LUMEN CATHETER. THE FACILITY ADVISED THEY WOULD BE CONTACTING ARROW INTERNATIONAL REGARDING THE DEVICE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER BROKE. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE THE CIRCUMSTANCES AND CONDITIONS AT THE TIME OF THE EVENT. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT AS OF THE DATE OF THIS REPORT. THE DEVICE IS BEING RETURNED BY THE CUSTOMER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556764 TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1