BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 14 GA X 8IN (20 CM)

    MDR report key: 2864442 · Received December 5, 2012

    Report

    Report Number
    1036844-2012-00346
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    June 28, 2012
    Report Date
    December 5, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K820009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE EXTENSION LINE OF THE CATHETER AND THE CONNECTOR CATHETER. THE LEAK OCCURRED IN THE CARDIO VASCULAR DEPARTMENT. THERE WAS A RISK OF EMBOLISM, SO THE CATHETER WAS REMOVED AND A NEW CATHETER WAS SUCCESSFULLY INSERTED. THERE WAS A DELAY IN TREATMENT WITH NO HARM TO THE PATIENT AND NO COMPLICATIONS OR DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 14 GA X 8IN (20 CM) SINGLE LUMEN CVC PRODUCTS DQY ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK