BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5F DBL LMN VASC-PICC/FULL NURSING

    MDR report key: 2002398 · Received January 28, 2011

    Report

    Report Number
    2518902-2011-00001
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDCOMP
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. ADDITIONAL INFO ABOUT THE PT, DEVICE AND EVENT HAS BEEN REQUESTED. WHEN THE INVESTIGATION IS COMPLETE A FINAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER LEAKED WHERE THE LUER MEETS THE EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5F DBL LMN VASC-PICC/FULL NURSING INFUSION PICC LJS MEDCOMP MRVSP52003 MBBW430

    Patients

    Seq Age Sex Outcome Treatment
    1 NI