BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC

    MDR report key: 5095859 · Received September 22, 2015

    Report

    Report Number
    3006260740-2015-00433
    Event Type
    Injury
    Date Received
    September 22, 2015
    Report Date
    September 1, 2015
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PER SALES REPRESENTATIVE, FACILITY CALLED TO ASK IF THE PICC TIP IN THE CAJ OR THE RIGHT ATRIUM CAN CAUSE VTACH. THEY CURRENTLY USE THE 3CG TO CONFIRM. AN INCIDENT REPORTEDLY OCCURRED WHERE PLACERS SAID THEY HAD GREAT P-WAVES AND NO NEGATIVE BUT PATIENT ALLEGEDLY WENT INTO VTACH. THIS TIME READ RA (AWARE OF SUBJECTIVITY HERE). PLACER REPORTEDLY PULLED BACK AND PATIENT WAS SAID TO BE FINE. NO ADDITIONAL EVENTS DETAILS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624149 PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention