BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PICC

    MDR report key: 11275000 · Received February 3, 2021

    Report

    Report Number
    3006260740-2021-00199
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 14, 2021
    Report Date
    January 16, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A HEMORRHAGIC STROKE OCCURRED AND RESULTED IN A LIFE-THREATENING ILLNESS OR INJURY, RESULTED IN A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION, RESULTED IN IN-PATIENT OR PROLONGED HOSPITALIZATION. HEALTH CARE PROFESSIONALS DON'T BELIEVE THE DEVICE CAUSED THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171960 BARD PICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention