BEUDAMED
    FDA Adverse Event Death Summary report: N

    PPICC SOLO 5FR D/L, 3CG

    MDR report key: 17585681 · Received August 21, 2023

    Report

    Report Number
    3006260740-2023-03594
    Event Type
    Death
    Date Received
    August 21, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 4, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ONCOLOGY PATIENT WAS NEEDING TRIPLE ANTIBIOTIC THERAPY WITH LOW PLATELETS. PRIOR TO PICC INSERTION HEMATOLOGIST CONFIRMED PATIENT WAS SUITABLE FOR PICC INSERTION. UNCOMPLICATED PICC INSERTION. NEW INFORMATION THAT DEATH WAS 4 DAYS POST DISCHARGE FROM HOSPITAL AND AFTER PICC INSERTION. PATIENT DIED WITH PICC IN SITU. UNKNOWN DETAILS AROUND DEATH INCLUDING TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459165 PPICC SOLO 5FR D/L, 3CG 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 Death