BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH 5 FR PICC

    MDR report key: 1793492 · Received August 7, 2010

    Report

    Report Number
    2925153-2010-00014
    Event Type
    Other
    Date Received
    August 7, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 4, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ASSESSED AND DETERMINED TO BE A MDR REPORT BASED ON OUR MDR REPORTING CRITERIA. THE INFORMATION PROVIDED WITH THE REPORT TO DATE SUGGESTS PHYSICAL DAMAGE. THE INVESTIGATION WILL BE CARRIED OUT TO DETERMINE THE CAUSE OF THE ISSUE. AN EXAMINATION OF THE OPENED DEVICE CANNOT BE CARRIED OUT AS THE USED ITEM(S) WAS NOT RETURNED TO NEOMEDICAL. HOWEVER, THE UNUSED SAMPLES WILL BE EXAMINED AS PART OF THE EXAMINATION.

    Description of Event or Problem · 1

    BASED ON THE REPORT INFORMATION, SUBMITTED TO NEOMEDICAL ON (B)(6) 2010, THE CUSTOMER STATED THAT IN PREPARING TO INSERT A PICC LINE THERE WAS NO HOLE IN THE DILATOR. THE CUSTOMER DISCARDED THE SAMPLE BUT RETURNED THREE UNUSED TRAYS WITH THE SAME PRODUCT NUMBER AND LOT NUMBER. NO OTHER INFORMATION HAS BEEN MADE AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH 5 FR PICC V-CATH 5 FR DQY NEOMEDICAL 5023-2660 1002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention