BEUDAMED
    FDA Adverse Event Injury Summary report: N

    400CC PMP KIT W2SITE 5.0EXFEN

    MDR report key: 1033809 · Received April 24, 2008

    Report

    Report Number
    2648666-2008-00053
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    April 12, 2007
    Report Date
    April 17, 2008
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    MEB
    PMA / PMN Number
    K043466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVAL. IT WAS REPORTED THAT THE CATHETER WAS SUTURED IN PLACE AND THAT THE CATHETER WAS CUT DURING REMOVAL. THE INSTRUCTIONS FOR USE WARN AGAINST SUTURING THE CATHETER IN PLACE AND ABOUT CUTTING THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CATHETER REMOVAL, THE PT TRIED TO CUT THE STITCH HOLDING THE CATHETER IN PLACE BUT ENDED UP CUTTING ONE OF THE CATHETERS INSTEAD AND THE CATHETER RETRACTED BACK INTO HER STOMACH. IT WAS DECIDED AT THAT TIME TO LEAVE THE CATHETER IN PLACE. APPROX 6 MONTHS LATER, THE PT CAME IN AS SHE FELT SOMETHING TUBELIKE IN HER LOWER ABDOMEN. AN X-RAY REVEALED WHAT APPEARED TO BE A PIECE OF CATHETER. SURGERY WAS DONE TO OPEN THIS AREA BUT ONLY SCAR TISSUE WAS PRESENT. RECENTLY THE PT CAME IN STATING SHE FELT SOMETHING POKING OUT HER RIGHT UPPER FOREARM AREA NEAR HER ELBOW. IT WAS REPORTED THAT A SMALL INCISION WAS MADE AND A NINE INCH PIECE OF CATHETER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 400CC PMP KIT W2SITE 5.0EXFEN INFUSION PUMP MEB STRYKER INSTRUMENTS PUERTO RICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention