BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPICUTANEO-CAVE CATHETER 24G

    MDR report key: 2431872 · Received January 3, 2012

    Report

    Report Number
    2245270-2012-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    November 11, 2011
    Report Date
    January 30, 2012
    Manufacturer
    VYGON CORP.
    Product Code
    LJS
    PMA / PMN Number
    K897168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL, BUT PICTURES OF THE PRODUCT MALFUNCTION WERE SUBMITTED AND FORWARDED TO VYGON (B)(4) FOR INVESTIGATION. ADD'L INFO WILL BE PROVIDED WITHIN 30 OF THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING INSERTION OF PICC THE CATHETER WAS FLUSHED AND A "BALLOON" FORMED JUST DISTAL TO THE EXTENSION SET. THE PICC WAS REMOVED, DISCARDED AND REPLACED WITH ANOTHER CATHETER. THE PT SUFFERED NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPICUTANEO-CAVE CATHETER 24G CATHETER, INTRAVASCULAR, LONG TERM, PICC LJS VYGON CORP. 2184.00

    Patients

    Seq Age Sex Outcome Treatment
    1