BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO-LINE CT

    MDR report key: 20048587 · Received August 23, 2024

    Report

    Report Number
    20048587
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    June 4, 2024
    Report Date
    August 6, 2024
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD DOUBLE LUMEN HICKMAN PLACED BY IR ON [REDACTED DATE]. ON [REDACTED DATE], RN DOCUMENTED THAT THE "WHITE PORT ON HICKMAN" WAS "CRACKED." ON [REDACTED DATE], INTERVENTIONAL RADIOLOGY CONSULTED ON THE PATIENT AND DOCUMENTED THAT "IR WILL PLAN TO EXCHANGE IN THE NEXT FEW DAYS" AND THAT THE "NON-CRACKED LUMEN IS OKAY FOR USE." PATIENT INITIALLY SCHEDULED FOR HICKMAN EXCHANGE ON [REDACTED DATE]. HOWEVER, ON [REDACTED DATE], RN DOCUMENTED "PATIENT SUPPOSED TO GO TO IR FOR HICKMAN REPAIR BUT REFUSED TO STICK TO NPO (NOTHING BY MOUTH) STATUS, EDUCATED THAT NOT STAYING NPO MEANS PROCEDURE WILL BE DELAYED, PT UNDERSTOOD AND REQUESTED IT BE RESCHEDULED. MD NOTIFIED AND WENT TO BEDSIDE AND PT AND FAMILY CONTINUED TO WANT APPOINTMENT TO BE RESCHEDULED." PATIENT UNDERWENT HICKMAN EXCHANGE IN INTERVENTION RADIOLOGY ON [REDACTED DATE].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071319 PRO-LINE CT CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS MEDICAL COMPONENTS, INC. MRCTC72001 MRGC450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose