BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PICC

    MDR report key: 18387364 · Received December 22, 2023

    Report

    Report Number
    3006260740-2023-05857
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    October 28, 2023
    Report Date
    December 11, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER VIA MEDWATCH, "PICC ASSOCIATED THROMBUS LIKELY DUE TO INCORRECT PICC PLACEMENT. PICC PLACEMENT WAS VERIFIED BY SHERLOCK 3CG TECHNOLOGY FROM BARD ACCESS SYSTEMS, PICC WAS DEEP IN THE RA LIKELY SHEERING WALL AND CAUSING MURAL THROMBUS, WHICH IS POSSIBLE CULPRIT FOR PARADOXICAL EMBOLI CAUSING STROKE IN THE PATIENT." NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264853 BARD PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention