BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 16 GA X 12

    MDR report key: 2013789 · Received February 4, 2011

    Report

    Report Number
    9680794-2011-00007
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 2, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K820009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    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 A WEEK AFTER THE CATHETER WAS INDWELLED, THE MEDICAL SOLUTION LEAKED AT THE JUNCTION HUB WHILE THE PATIENT WAS IN THE HOSPITAL WARD. AS A RESULT, THE CATHETER WAS REMOVED, BUT NOT REPLACED AS THE TREATMENT WAS COMPLETE AS SCHEDULED. THE CLINICIAN NOTED THAT THERE WAS NO PROBLEM DURING THE FLUSHING OF THE CATHETER. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 16 GA X 12 SINGLE LUMEN CVC PRODUCTS DQY ARROW INTERNATIONAL INC CF0091661

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK