BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 4FR X 1 3CM

    MDR report key: 3021021 · Received March 20, 2013

    Report

    Report Number
    3006425876-2013-00031
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ARROW INTERNATIONAL CINC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PEDIATRIC INTENSIVE CARE UNIT WHEN RINSING THE DISTAL LUMEN, THERE WAS A RETURN OF PRODUCT INTO THE PROXIMAL LUMEN WHICH SUGGESTS THERE WAS A COMMUNICATION BETWEEN THE TWO CHANNELS. THE INSERTION SITE IS UNK. THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO DELAY IN TREATMENT AND NO PT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115851 CVC SET: 2-LUMEN 4FR X 1 3CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL CINC ZF0044481

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK