BEUDAMED
    FDA Adverse Event Death Summary report: N

    47 CM SINGLE LUMEN CATHETER PICC

    MDR report key: 20420375 · Received October 9, 2024

    Report

    Report Number
    MW5160945
    Event Type
    Death
    Date Received
    October 9, 2024
    Date of Event
    August 30, 2024
    Report Date
    October 4, 2024
    Manufacturer
    ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 47 CM, SINGLE LUMEN CATHETER/ ARROW LOT NUMBER: 33F24B0527. RIGHT ARM, BASILIC VEIN. STERILE CHLORHEXIDINE GLUCONATE GEL DRESSING. START 12:15 END 12:27. RAPID RESPONSE TEAM CALLED FOR CONDITION CHANGE. PATIENT MINIMALLY RESPONSIVE TO PAINFUL STIMULATION. PATIENT PRESENTLY SLUMPED OVER IN BEDSIDE RECLINER. EXTREMITIES ESSENTIALLY FLACCID, POSSIBLY WITH RECENT POSTURING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319339 47 CM SINGLE LUMEN CATHETER PICC CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) 33F24B0527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death