BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 4 FR X 8 CM

    MDR report key: 3900300 · Received May 6, 2014

    Report

    Report Number
    1036844-2014-00216
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 28, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE PEDIATRIC ICU WHEN TRANSPORTING THE 3 YEAR OLD FEMALE PATIENT FROM THE STRETCHER TO THE BED, IT WAS NOTICED THAT THE CATHETER BEGAN TO "EXIT" AS A RESULT OF BROKEN SUTURE WINGS. AS A RESULT, A DIFFERENT ACCESS WHICH WAS ALREADY IN PLACE WAS SUCCESSFULLY USED. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271692 CVC SET: 2-LUMEN 4 FR X 8 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCT DQY ARROW INTL., INC. 23F13G0452

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR