BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 2SS CV

    MDR report key: 10241868 · Received July 7, 2020

    Report

    Report Number
    9616066-2020-02055
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    May 18, 2020
    Report Date
    June 16, 2020
    Manufacturer
    CFN MEXICO 215 SA DE CV
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.4. DATE EVENT REPORTED TO CFN: 2020-06-16. G.4. REPORTABLE AWARE DATE: 2020-06-16.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS LVP 20D 2SS CV TUBING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2420-0007 BATCH NO: 20013299 IT WAS REPORTED THE RN PRIMED THE TUBE AND NOTICE LEAKING FROM THE LINE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS LVP 20D 2SS CV TUBING LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 2420-0007 BATCH NO: 20013299 IT WAS REPORTED THE RN PRIMED THE TUBE AND NOTICE LEAKING FROM THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702174 AS LVP 20D 2SS CV SET, ADMINISTRATION, INTRAVASCULAR FPA CFN MEXICO 215 SA DE CV 2420-0007 20013299 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 20200518