BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7 FR X 30 CM

    MDR report key: 3050253 · Received April 5, 2013

    Report

    Report Number
    1036844-2013-00129
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ARROW INTL., 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 WAS REPORTED THAT RESISTANCE WAS MET DURING INSERTION OF THE GUIDE WIRE THRU THE ARROW RAULERSON SYRINGE (ARS). UPON REMOVAL OF THE GUIDE WIRE FROM THE ARS THE GUIDE WIRE WAS NOTED TO BE UNRAVELED. AS A RESULT THE DEVICE WAS REMOVED AND REPLACED. THERE WAS A DELAY IN TREATMENT WITH; NO DEATH OR PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141733 CVC SET: 3-LUMEN 7 FR X 30 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF2072278

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK