BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOMEDICAL V-CATH PICC

    MDR report key: 1741478 · Received June 28, 2010

    Report

    Report Number
    2925153-2010-00009
    Event Type
    Other
    Date Received
    June 28, 2010
    Report Date
    June 25, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INFO PROVIDED WITH THE REPORT IS SKETCHY. ADDITIONAL INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. AN EXAMINATION OF THE DEVICE(S) HAS NOT BEEN CARRIED OUT AS THE USED ITEM(S) WAS NOT RETURNED TO NEOMEDICAL.

    Description of Event or Problem · 1

    BASED ON THE REPORT INFO, SUBMITTED TO NEOMEDICAL ON (B)(6) 2010, CUSTOMER COMPLAINED THAT THERE HAVE BEEN 7 INCIDENTS OF LEAKING. THE PRODUCT MENTIONED IS (B)(4), LOT # 1083. NO OTHER INFO HAS BEEN MADE AVAILABLE. THE USED PRODUCTS/SAMPLES WERE NOT RETURNED TO NEOMEDICAL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOMEDICAL V-CATH PICC V-CATH 2 FR PICC DQY NEOMEDICAL 355-72 1083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention