BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL PASV PICC

    MDR report key: 877030 · Received July 10, 2007

    Report

    Report Number
    6000126-2007-00075
    Event Type
    Malfunction
    Date Received
    July 10, 2007
    Date of Event
    June 5, 2007
    Report Date
    June 18, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LJS
    PMA / PMN Number
    K021704
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT REPORTED THAT THE DEVICE WILL NOT BE RETURNED TO THIS MANUFACTURER AS IT WAS DISCARDED SUBSEQUENT TO THE EVENT; CONSEQUENTLY, A FAILURE ANALYSIS OF THE DEVICE CAN NOT BE PERFORMED. WE ARE UNABLE TO DETERMINE IF THE DEVICE MET SPECIFICATION. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. ALL RECORDS APPEARED NORMAL AND NO RELATED QUALITY ISSUES OR MANUFACTURING DEFICIENCIES WERE NOTED AT THE TIME OF MANUFACTURE. A BATCH/LOT HISTORY SEARCH WAS PERFORMED ON THIS DEVICE'S REPORTED BATCH/LOT NUMBER OF 1162685. THERE HAVE BEEN NO PREVIOUS COMPLAINTS REPORTED AGAINST LOT 1162685. THERE WERE NO CURRENT ADVERSE TRENDS DETECTED FOR "HOLE IN CATHETER". IN ADDITION, THE MAY 2007 15-MONTH PICCS VALVED COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURES MODES WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED AND NO DATA POINT EXCEEDED THE COMPLAINT ALERT LIMIT. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT A VAXCEL PASV PICC HAD BEEN THERAPEUTICALLY IMPLANTED IN THE BASILIC VEIN OF A PATIENT (AGE AND GENDER UNKNOWN) IN 2007. THREE MONTHS LATER, THE CLINICIANS OBSERVED THAT THE PICC LINE HAD A HOLE LOCATED DISTAL TO THE SUTURE WING WHERE THE CATHETER EXITS THE SKIN. THE CLINICIANS EXPLANTED THE DEVICE AND SUCCESSFULLY REPLACED IT WITH ANOTHER PICC. THE COMPLAINANT REPORTED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT AS A RESULT OF THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PASV PICC LJS BOSTON SCIENTIFIC NA 1162685

    Patients

    Seq Age Sex Outcome Treatment
    1 YR