BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH

    MDR report key: 734331 · Received June 29, 2006

    Report

    Report Number
    2925153-2006-00023
    Event Type
    Other
    Date Received
    June 29, 2006
    Date of Event
    February 3, 2006
    Report Date
    June 29, 2006
    Manufacturer
    HDC CORPORATION
    Product Code
    DQO
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HDC CORPORATION DID NOT RECEIVE ADD'L INFO REQUESTED. INSUFFICIENT DATA; UNABLE TO UNDERSTAND THE INCIDENT BETTER. FILING AS MDR DUE TO LACK OF INFO FROM COMPLAINANT. NO SAMPLE WAS RETAINED TO VERIFY VALIDITY OF CLAIM.

    Description of Event or Problem · 1

    "PICC LINE WAS PLACED IN NEONATE. AFTER FEW HOURS OF USE, LINE BROKE OFF AT THE 'HUB' CONNECTION, LINE WAS REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH ACCESS DEVICE DQO HDC CORPORATION 355-75 1054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other