BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD TL PICC

    MDR report key: 15781264 · Received November 11, 2022

    Report

    Report Number
    3006260740-2022-05020
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    April 14, 2021
    Report Date
    October 19, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 DURING CLINICAL ASSESSMENT. REDNESS OR SWELLING WAS IDENTIFIED AT OR AROUND THE CENTRAL LINE INSERTION SITE. THIS EVENT INVOLVES 1 TL PICC UPPER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2878122 BARD TL 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