BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY

    MDR report key: 8624303 · Received May 20, 2019

    Report

    Report Number
    1820334-2019-01232
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Report Date
    June 14, 2019
    Manufacturer
    COOK INC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    IN ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019, THE AREA REP CONFIRMED THAT THE TOTAL NUMBER OF OCCURRENCES OF LEAKING DEVICES AT THIS FACILITY IS FOUR. THESE FOUR EVENTS HAVE PREVIOUSLY BEEN REPORTED UNDER THE MFG. REPORT REFERENCE #'S 1820334-2019-01061, 1820334-2019-01062, 1820334-2019-01063 AND 1820334-2019-01064. AS THIS REPORT (MFG. REPORT REFERENCE # 1820334-2019-01232) IS A DUPLICATE, NO FURTHER REPORTS WILL BE SENT FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    COMMON NAME & PRODUCT CODE: UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. OCCUPATION: SYSTEMS RISK MANAGER. PMA/510(K) NUMBER: UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. 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 THAT THE COOK SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER LEAKS. THE NEONATAL INTENSIVE CARE UNIT (NICU) REPORTED "SEVERAL EPISODES" OVER THE PAST FEW WEEKS. NO PATIENT HARM HAS BEEN REPORTED. NO LOT NUMBER IS AVAILABLE. NO FURTHER INFORMATION REGARDING THE EVENT HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418658 SINGLE LUMEN POLYETHYLENE CENTRAL VENOUS CATHETER TRAY FOZ COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1