BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN CVC KIT: 3-L 7 FR X 6IN (16 C

    MDR report key: 2061521 · Received March 16, 2011

    Report

    Report Number
    2242445-2011-00033
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    December 25, 2010
    Report Date
    March 14, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    FOZ
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REFERENCE MDR #2242445-2011-00003 FOR FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT UPON RECEIPT OF THE SAMPLE FOR INVESTIGATION OF THE FIRST EVENT, IT WAS NOTED THAT TWO SPRING WIRE GUIDE'S (SWG) WERE RETURNED FOR EVALUATION. THIS GUIDEWIRE WAS FOUND TO BE UNRAVELED. ADDITIONAL INFO RECEIVED ON (B)(6) 2011 FROM THE HOSPITAL CONTACT STATED THE TWO WIRES WITH THE CATHETER WERE PLACED ON HER DESK AND SHE BELIEVES THEY ARE FROM THE SAME INSERTION. THE SECOND ATTEMPT WAS SUCCESSFUL AND THIS MAY BE THE SECOND SWG USED OR THEY ALSO HAVE SEPARATELY PACKAGE SWG'S AVAILABLE IF THEY CONTAMINATE ONE FROM OTHER COMPETITORS. THERE WAS NO FURTHER INFO SINCE THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN CVC KIT: 3-L 7 FR X 6IN (16 C ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTL., INC. RF0089292

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK