BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7FR X 2 0CM

    MDR report key: 1915558 · Received November 5, 2010

    Report

    Report Number
    3006425876-2010-00075
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    October 10, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    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 #3006425876-2010-00074 FOR THE FIRST EVENT AND MDR #3006425876-2010-00076 FOR THE THIRD EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE INSERTION OF THE NEEDLE, SPRING WIRE GUIDE (SWG) AND CATHETER WERE ALL NOTED AS "GOOD" AND WITHOUT EVENT. DURING THIS SECOND ATTEMPT, THERE WAS DIFFICULTY WITH THE REMOVAL OF THE SWG; IT "FRAYED" OUT OF THE GUIDE. THERE WAS A 10 MINUTE DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7FR X 2 0CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC ZF0088978

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR