BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRAL CATHETER-PICC LINE

    MDR report key: 19184686 · Received April 24, 2024

    Report

    Report Number
    MW5154313
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    December 6, 2023
    Report Date
    December 13, 2023
    Manufacturer
    FOOTPRINT MEDICAL LNC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE FOUND BROKEN OFF AT THE HUBB, 14 CM REMAINED INTERNAL AND 3 CM EXTERNAL. TEGRADERM DRESSING INTACT, POSIES TO NEONATES ARM STILL SECURE. NO FLUSHING OF LINE FOLLOWING INSERT. 10CC SYRINGE USED DURING INSERTION, CONTINUOUS INFUSION OF D (B)(4) FOLLOWING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879250 CENTRAL CATHETER-PICC LINE CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS FOOTPRINT MEDICAL LNC. 231071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female