BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.4 FR SINGLE LUMEN CATHETER

    MDR report key: 23923295 · Received December 30, 2025

    Report

    Report Number
    MW5181453
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 19, 2025
    Report Date
    December 22, 2025
    Manufacturer
    FOOTPRINT MEDICAL INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEONATE HAD RIGHT ARM PICC THAT WAS FOUND TO BE SNAPPED APART WHEN THE RN WENT INTO THE ISOLETTE. NO APPARENT REASON FOR BREAKAGE. FOOTPRINT PICC 1.4FR PLACED ON (B)(6) 2025. CATHETER LOT #: 250708 PRODUCT EXPIRATION DATE: 9/18/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2585105 1.4 FR SINGLE LUMEN CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS FOOTPRINT MEDICAL INC. 250708

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Female