BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD MINIBORE EXTENSION SET - 60 INCH, SPIN COLLAR

    MDR report key: 20609489 · Received November 5, 2024

    Report

    Report Number
    20609489
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    August 3, 2024
    Report Date
    August 7, 2024
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FPA
    UDI-DI
    00887709094154
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PARENTS NOTICED LEAKING FROM BED ONTO FLOOR. RN ASSESSED SITUATION AND FOUND MED TUBING BETWEEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE AND MANIFOLD TO BE CRACKED AND LEAKING. NEONATAL NURSE PRACTITIONER (NNP) [NAME REDACTED] CALLED. MANIFOLD HOOKED UP DIRECTLY TO PICC LINE PER NNP. NO MORE LEAKING NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47338 LIFESHIELD MINIBORE EXTENSION SET - 60 INCH, SPIN COLLAR SET, ADMINISTRATION, INTRAVASCULAR FPA HOSPIRA, INC. 1440228 13947271 00887709094154

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Male