BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD TL DIALYSIS CATHETER

    MDR report key: 15781479 · Received November 11, 2022

    Report

    Report Number
    3006260740-2022-05028
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    May 11, 2021
    Report Date
    October 21, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    MPB
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE FOLLOWING WAS OBTAINED DURING CLINICAL ASSESSMENT. FLUID LEAKING FROM CENTRAL LINE INSERTION SITE." THE EVENT INVOLVED 1 TL DIALYSIS INSERTED FEMORALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2689141 BARD TL DIALYSIS CATHETER CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB C.R. BARD, INC. (BASD) -3006260740 N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other