BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE

    MDR report key: 16731665 · Received April 13, 2023

    Report

    Report Number
    16731665
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 26, 2023
    Report Date
    March 28, 2023
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CASE #1: LIPIDS NOTED TO BE LEAKING FROM CRACKED IV TUBING AND ON FLOOR OF IV POLE. INFANT DID NOT RECEIVE ALL OF LIPID INFUSION. CASE #2: WHEN ASSESSING PATIENT AT THE BEDSIDE, REGISTERED NURSE (RN) NOTICED THAT THE LIPIDS WERE LEAKING DOWN THE TUBING OUTSIDE OF THE PATIENT BED. UPON FURTHER INVESTIGATION THE LIPID TUBING WOULD NOT TIGHTEN ONTO THE TIP OF THE SYRINGE APPROPRIATELY. NIGHT RN CHANGED LIPID TUBING EARLY ON DUE TO LEAKING BECAUSE THEY THOUGHT IT WAS THE TUBING BUT IT APPEARS TO BE THE TIP OF THE SYRINGE. PHARMACY WAS NOTIFIED AND NEONATAL NURSE PRACTITIONER (NNP) ADVISED RN TO TURN LIPIDS OFF. CASE #3: NIGHT SHIFT REGISTERED NURSE CHANGED LIPID TUBING DUE TO BLOOD BACKING UP IN PICC LINE AND NOTED LEAKING. DAYSHIFT REGISTERED NURSE ASSESSED INFANT AND NOTICED LIPIDS WERE LEAKING DOWN THE TUBING RIGHT WHERE THEY ARE CONNECTED TO THE SYRINGE ON THE IV PUMP. PHARMACY AND NNP WERE CONTACTED. NEW LIPIDS TO BE HUNG WITH FRESH TUBING AND OLD LIPIDS ALONG WITH TUBING GIVEN TO PHARMACY. MANUFACTURER RESPONSE FOR 60" IV EXTENSION SET, PRODUCT # DYNDTN1603 (MEDLINE) (PER SITE REPORTER). UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    979216 MEDLINE SET, ADMINISTRATION, INTRAVASCULAR FPA MEDLINE INDUSTRIES, INC. DYNDTN1603 (10)0332210A194

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown