BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 8FR X 2 0CM

    MDR report key: 3050391 · Received April 8, 2013

    Report

    Report Number
    3006425876-2013-00043
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 5, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT IS REPORTED THIS EVENT OCCURRED IN THE SURGICAL INTENSIVE CARE UNIT. THE SEX OF THE PATIENT AND INSERTION SITE IS UNKNOWN. AFTER INSERTION OF THE CATHETER OVER THE WIRE, THE CLINICIAN REMOVED THE GUIDE WIRE AND FOUND IT WAS FRACTURED. THE DILATOR WAS NOT KINKED AND THERE WAS NO OBSTRUCTION WHEN INSERTING THE GUIDE WIRE. THERE IS NO REPORTED DELAY OR INTERRUPTION TREATMENT. THERE IS NO REPORTED PATIENT INJURY, COMPLICATION OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144398 CVC SET: 2-LUMEN 8FR X 2 0CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. ZF2053388

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK