BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.9FX50CM SINGLE LUMEN VASCU-PICC

    MDR report key: 2110941 · Received April 15, 2011

    Report

    Report Number
    2518902-2011-00029
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    December 30, 2010
    Report Date
    April 11, 2011
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE "PICC LINE SNAPPED AT CONNECTION TO THE WHITE HUB COMPONENT DURING A DRESSING CHANGE. PATIENT HAD A NEW PICC LINE PLACED AFTER THIS ONE WAS REMOVED. PATIENT DID NOT SUFFER ANY UNTOWARD CONSEQUENCES FROM THE PROCEDURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.9FX50CM SINGLE LUMEN VASCU-PICC INFUSION CATHETER-PICC LJS MEDCOMP MR17011101 MBBA340

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Required Intervention