BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED PICC

    MDR report key: 2620843 · Received June 8, 2012

    Report

    Report Number
    3006260740-2012-00192
    Event Type
    Injury
    Date Received
    June 8, 2012
    Report Date
    May 18, 2012
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PER SUMMONS: PT PRESENTED TO RELATOR AS A NEW OFFICE PT WITH A PROGRESS NOTE INDICATING HYPERCOAGUABLE STATE. THE PT HAD A PE 1/05 UPPER EXTREMITY DVT SECONDARY TO PICC LINE 1/07, AND ANOTHER PE IN (B)(6) WITH SUBSEQUENT INFARCT. PT Q IS A SICKLE CELL THALASSEMIA PT, AND RELATOR HAS BEEN PREVIOUSLY ADVISED THAT SOME SICKLE CELL CLINICS WERE USING PICC LINES INAPPROPRIATELY AND EXPERIENCING A HIGH COMPLICATION RATE DUE TO THE HYPERCOAGULABILITY ASSOCIATED WITH SICKLE CELL ANEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTED PICC PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER LJS BARD REYNOSA S.A. DE C.V. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention