BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 12 FR X 20 CM

    MDR report key: 2904030 · Received January 3, 2013

    Report

    Report Number
    3006425876-2013-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 3, 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). THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. UPON RECEIPT OF THE RETURNED DEVICE ON (B)(4) 2013, THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE IT IS REPORTABLE. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THIS EVENT OCCURRED IN THE EICU. THE INSERTION SITE IS UNKNOWN. WHEN THE GUIDE WIRE WAS PLACED INTO THE ARS, THE GUIDE WIRE KINKED. AS A RESULT, A NEW KIT WAS OPENED AND USED SUCCESSFULLY. THERE WAS NO REPORTED DELAY. THERE WAS NO REPORTED PT COMPLICATIONS, INJURIES, OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3539 CVC SET: 3-LUMEN 12 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. ZF2041847

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK