BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 3820945 · Received April 15, 2014

    Report

    Report Number
    1036844-2014-00176
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED IN TO THE PATIENT'S RIGHT SUBCLAVIAN IN THE EMERGENCY DEPARTMENT. DURING INSERTION, THE SPRING WIRE GUIDE BECAME UNRAVELED AND STRETCHED. AS A RESULT, THE CATHETER AND WIRE WERE REMOVED AS ONE. ANOTHER KIT WAS USED SUCCESSFULLY FOR THE PATIENT. THERE WERE NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230760 CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS DQY ARROW INTL., INC. 23F13L0472

    Patients

    Seq Age Sex Outcome Treatment
    1