BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 3-LUMEN 7FR X 20CM

    MDR report key: 6090223 · Received November 9, 2016

    Report

    Report Number
    3006425876-2016-00350
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 2, 2016
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ADDITIONAL INFORMATION: THIS PRODUCT IS NOT SOLD IN THE US. THE 510K # PROVIDED IS FOR A SIMILAR PRODUCT THAT IS SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED AT THE CCV 9I UNIT. THE FIXATION (BOX CLAMP) DID NOT FIX PROPERLY THE CVC. THE CVC SLIPPED OUT OF THE PATIENT AND A SECOND CVC HAD TO BE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742039 CVC SET: 3-LUMEN 7FR X 20CM ADULT MULTI LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. 71F16H0266

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention