BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC SOLO CATH W/SHERLOCK 3CG TPS STYLET 5F W/MIC

    MDR report key: 3890815 · Received June 4, 2014

    Report

    Report Number
    3006260740-2014-00285
    Event Type
    Injury
    Date Received
    June 4, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL, AS THE DEVICE REMAINS IN THE PT. A LOT HISTORY REVIEW (LHR) OF REXL0672 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    THE ECG READING FROM THE 3CG SAID PICC TIP RESIDED IN BOTTOM THIRD OF SVC FOR AN ICU PT. PT HAD GUILLIAN BARRE DISEASE. PICC WAS PLACED ON THE RIGHT SIDE. THE PICC TIP WAS CONFIRMED TO BE IN LOWER SVC BY AN XRAY WHICH WAS ORDERED FOR AN UNRELATED ISSUE LATER THAT DAY. WITHIN 18 HOURS OF PICC INSERTION, NURSES PUT PT ON HIS SIDE AND PT WENT INTO VTAC. HAPPENED AGAIN WHEN THEY WERE PUT ON THEIR SIDE THE NEXT DAY. NURSE CHECKED PICC AND CONFIRMED EXTERNAL SEGMENT WAS STILL 4CM (SAME AT TIME OF PLACEMENT). DOCTOR ORDERED PICC TO BE PULLED BACK 2 CM AND WAS THEN X-RAYED AGAIN. X-RAY SAID THAT THE PICC WAS ACCURATELY PLACED AT CAVOATRIAL JUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327492 POWERPICC SOLO CATH W/SHERLOCK 3CG TPS STYLET 5F W/MIC LJS BARD ACCESS SYSTEMS REXL0672

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention