BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC NATE

    MDR report key: 811786 · Received January 12, 2007

    Report

    Report Number
    1718873-2007-00002
    Event Type
    Injury
    Date Received
    January 12, 2007
    Date of Event
    November 26, 2006
    Report Date
    December 6, 2006
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 2 FR SILICONE PICC WAS REPORTED TO HAVE ERODED THROUGH THE JUGULAR VEIN AFTER INDWELLING FOR FOUR DAYS, CAUSING RIGHT SIDED PLEURAL EFFUSION. UTMD WAS UNABLE TO LEARN OF THE NEONATE'S CONDITION FOLLOWING THE EVENT. THE CATHETER WAS NOT RETURNED FOR UTMD EVAL. THIS IS THE FIRST REPORT (TOGETHER WITH ANOTHER MEDWATCH FILED BY THE SAME INSTITUTION FOR A BASILICA VEIN EROSION OCCURRING IN ANOTHER PT ON THE SAME DAY, IN WHICH A PICC FROM THE SAME LOT WAS INSERTED ON THE SAME DAY) OF VASCULAR EXCORIATION OR EROSION, SINCE, THE 2 FR SILICONE PICC WAS CLEARED FOR MARKETING UNDER 510(K) NUMBER K001874 IN 2000. THIS CONSTITUTES A "RARE" EVENT. REVIEWS OF UTMD'S AND SILICONE TUBING VENDOR'S DOCUMENTATION, INDICATES NO CHANGES HAVE OCCURRED IN THE COMPOSITION OF THE MATERIAL OF THE CATHETER BODY. IN ADDITION, NO COMPLAINTS WHATSOEVER, HAVE BEEN RECEIVED BY UTMD TO DATE REGARDING 1345 CATHETERS ASSEMBLED AND SHIPPED TO CUSTOMERS FROM THE SAME LOT OF SILICONE TUBING. CLINICALLY, VASCULAR EROSION IS A RISK IN PICC PLACEMENTS, PARTICULARLY IN INSTANCES OF POOR INSERTION TECHNIQUE, MALPOSITIONING, OR INADEQUATE SECUREMENT LEADING TO MIGRATION; OR IN INSTANCES OF COMPROMISED NEONATAL CONDITION INCLUDING UNDERSIZED VASCULATURE RELATIVE TO THE SIZE OF THE CATHETER OR SEPSIS. PRODUCT NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC NATE 1.9 FR SILICONE CATHETER LJS UTAH MEDICAL PRODUCTS, INC. NA 1061975

    Patients

    Seq Age Sex Outcome Treatment
    1 24 DAY Required Intervention