BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICATH PERIPHERALLY INSERTED CATHETER

    MDR report key: 5161664 · Received February 6, 2004

    Report

    Report Number
    2183502-2004-00002
    Event Type
    Malfunction
    Date Received
    February 6, 2004
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC.)
    Product Code
    LJS
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE USED 16 GAUGE 65 CENTIMETER DUAL-LUMEN PICC LINE WAS RETURNED FOR EVALUATION. DURING VISUAL EXAMINATION IT WAS NOTED THE CATHETER WAS DAMAGED APPROXIMATELY 3/4 INCH DISTAL TO THE BIFURCATION. THE DAMAGE CONSISTS OF A RUPTURE ONE OF THE LUMENS, THE CATHETER MATERIAL APPEARS STRETCHED AS IF THE CATHETER WALL HAS BALLOONED AND RUPTURED. THIS KIND OF DAMGE IS CONSISTENT WITH OVER-PRESSURIZATION. THE RUPTURED LUMEN IS OCCLUDED WITH A MATERIAL CONSIST WITH DRIED BLOOD DISTAL TO THE RUPTURE AND THE CATHETER IS PT PROXIMAL TO THE RUPTURE. AS PER DIRECTION RECEIVED FROM THE FDA ON 12/09/1999;

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICATH PERIPHERALLY INSERTED CATHETER PICC LINE LJS SMITHS MEDICAL MD (FORMERLY DELTEC, INC.) 21-2984 M25166

    Patients

    Seq Age Sex Outcome Treatment
    1