BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPICUTANEO CAVA CATHETER SILICONE PICC

    MDR report key: 3894296 · Received February 19, 2014

    Report

    Report Number
    2245270-2014-00010
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    January 14, 2014
    Report Date
    February 18, 2014
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K897168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE OCCURRED WITH ANOTHER CATHETER OF THE SAME PRODUCT CODE AND LOT ON THIS PT. THE ADD'L OCCURRENCE IS DETAILED IN MDR 2245270-2014-00009. THE MFG DEVICE WAS RETURNED TO VYGON US AND WAS FORWARDED TO VYGON (B)(4), THE MFR, FOR DEVICE EVAL AND COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION WILL BE FORWARDED TO FDA VIA A F/U MDR WITHIN THIRTY DAYS OF ITS CONCLUSION.

    Description of Event or Problem · 1

    CENTRAL LINE PLACEMENT: LINE WAS FLUSHED WITH A 3ML SYRINGE CONTAINING NORMAL SALINE AFTER REMOVAL FROM PACKAGING AND NO HOLES OBSERVED. THE LINE WAS INSERTED INTO THE PT AND WAS PLACED APPROX 16.5CM. LINE WAS FLUSHED AND HOLE DEVELOPED AT POINT APPROX 1CM OUTSIDE OF THE PT. THE HOLE DEVELOPED WITHIN 5 MINUTES OF STARTING THE PROCEDURE. THIS LINE WAS REMOVED. APPROX 6MLS OF BLOOD LOST. THIS ISSUE OCCURRED WITH ANOTHER CATHETER OF THE SAME PRODUCT CODE AND LOT ON THIS PT. THE ADD'L OCCURRENCE IS DETAILED IN MDR 2245270-2014-00009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104364 EPICUTANEO CAVA CATHETER SILICONE PICC LONG TERM INTRAVASCULAR CATHETER LJS VYGON GMBH 2184.00 010313GE

    Patients

    Seq Age Sex Outcome Treatment
    1 207 DA