BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2864731 · Received December 6, 2012

    Report

    Report Number
    9680794-2012-00072
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 29, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ARROW INTERNATIONAL, INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE ICU WHEN TRYING TO CANNULATE THE FEMALE PT'S RIGHT SUBCLAVIAN VEIN, THE NEEDLE TWISTED AND BROKE FAR FROM THE HUB. NO SURGICAL INTERVENTION WAS NECESSARY AS THE PHYSICIAN WAS ABLE TO REMOVE THE NEEDLE. AS A RESULT, A NEW KIT WAS USED WITHOUT ISSUE. A DELAY WAS REPORTED, HOWEVER, THERE WERE NO ALARM TO THE PT DUE TO THIS DELAY OR AS A RESULT OF THIS OCCURRENCE. THE PT SUFFERED FROM RESPIRATORY INSUFFICIENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7FR X 3 0CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL, INC CF2068268

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK