BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-CATH PICC

    MDR report key: 1353122 · Received March 26, 2009

    Report

    Report Number
    MW5010517
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Report Date
    March 26, 2009
    Manufacturer
    NEOMEDICAL INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEOMEDICAL V-CATH PICC PERIPHERALLY INSERTED CATHETERS LEAKED AT THE STRAIN RELIEF SITE NECESSITATING THE REPLACEMENT AND/OR REPAIR OF THE CATHETER. MULTIPLE PLACEMENT OF PICC LINES THAT NEEDED TO BE EITHER REPLACED OR REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH PICC PICC LINE LJS NEOMEDICAL INC. 1027
    2 V-CATH PICC PICC LINE LJS NEOMEDICAL INC. 1029

    Patients

    Seq Age Sex Outcome Treatment
    1