BEUDAMED
    FDA Adverse Event Other Summary report: N

    V-CATH NEO MAGIC

    MDR report key: 1022561 · Received March 31, 2008

    Report

    Report Number
    2925153-2008-00001
    Event Type
    Other
    Date Received
    March 31, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 28, 2008
    Manufacturer
    HDC CORP.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARE IS REQUIRED WHEN USING THE 1.9 FR CATHETER. AN INVESTIGATION IS NEEDED TO CLARIFY THE INSERTION/REMOVAL CIRCUMSTANCES. THE PRODUCT SAMPLES HAVE NOT BEEN RETURNED FOR INVESTIGATION AS REQUESTED. ADD'L INFO REQUESTED HAS NOT BEEN RECEIVED. THERE WAS NO SERIOUS PT INJURY REPORTED.

    Description of Event or Problem · 1

    BASED ON THE REPORT, WHICH IS NOT VERIFIED, TWO PICC LINES SNAPPED WHILE THE PHYSICIAN WAS PLACING THE CATHETER IN THE BABY. ONE LINE SNAPPED ON THE OUTSIDE, THE OTHER ON THE INSIDE. THERE IS NO REPORT OF ANY PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-CATH NEO MAGIC ACCESS DEVICE LJS HDC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention