BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 FR D/L POWERPICC SOLO FULL TRAY

    MDR report key: 3810166 · Received April 29, 2014

    Report

    Report Number
    3006260740-2014-00217
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REWG1464 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    THERAPY/MED SURG MANAGER STATED THAT THEY USED TWO TRAYS WITH LOT # REYA2126 AND WITHIN TWO DAYS BOTH PATIENTS HAD BLOOD LOTS IN THEIR ARMS. ON (B)(6) 2014 - "PT HAD HIS PICC PLACED (B)(6) 2014 RIGHT BASILIC WITHOUT DIFFICULTY. ON (B)(6) 2014 NOTED SWELLING TO ARM WITH LARGE AMOUNT OF BRUISING-POSSIBLE DVT. NO ULTRASOUND DEPARTMENT AVAILABLE ON SATURDAY. MD ORDERED PICC REMOVED (B)(6) 2014 BY IVT. (PT WAS ON LOVENOX)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256230 5 FR D/L POWERPICC SOLO FULL TRAY LJS BARD ACCESS SYSTEMS REYA2126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention