BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 3932851 · Received March 11, 2014

    Report

    Report Number
    1036844-2014-00113
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    January 31, 2014
    Report Date
    February 5, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE PATIENT IN THE OPERATING ROOM. WHEN THE CLINICIAN WAS PULLING OUT THE WIRE FROM THE CATHETER, THE CENTRAL CORE WIRE SEVERED ALTHOUGH THE OUTER WIRE KEPT IT FROM SEPARATING COMPLETELY. THE WIRE WAS REMOVED INTACT. NO HARM WAS DONE TO THE PATIENT. THEY DO NOT KNOW IF THIS CAUSED A DELAY IN TREATMENT AND THERE WAS NO PATIENT DEATH OR COMPLICATIONS REPORTED. IT WAS NOTED THAT THERE WAS SOME RESISTANCE WHEN PUTTING IN THE DILATOR BUT NOTHING OUT OF THE ORDINARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146354 CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. 23F13K0117

    Patients

    Seq Age Sex Outcome Treatment
    1