BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE

    MDR report key: 16985974 · Received May 23, 2023

    Report

    Report Number
    9617594-2023-00195
    Event Type
    Malfunction
    Date Received
    May 23, 2023
    Date of Event
    May 1, 2023
    Report Date
    May 9, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619098476
    PMA / PMN Number
    K082836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SISTER SAMPLES FROM THE AFFECTED LOT NUMBER ARE AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, THEY HAVE NOT YET BEEN RECEIVED. ADDITIONAL INTERNAL CONTACT: (B)(4).

    Additional Manufacturer Narrative · 0

    THE FOLLOWING ITEMS WERE RECEIVED FOR INVESTIGATION: 2 NEW LIST #011-CH3142, 43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER; LOT #5970631. AS RECEIVED, THERE WAS NO CONTAMINATION OR PARTICULATE OF ANY KIND OBSERVED IN EITHER SAMPLE. NO MATTING DEVICE WAS RETURNED. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED BASED ON THE PHYSICAL SAMPLE EVALUATION. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. D9 - DATE RETURNED TO MFG:07-JUN-2023.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED A 43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER. THE CUSTOMER REPORTED EXPERIENCED AN ISSUE WITH THE 2, 3 AND 4 PRONG ATTACHMENT SET. DURING PRIMING AND WHEN CONNECTED TO AN IV LINE, THERE WERE SMALL BITS OF PLASTIC VISIBLE IN THE IV LINE. WHEN IT WAS DISCONNECTED FOR FURTHER INSPECTION, THERE WAS A LARGE PIECE OF PLASTIC IN THE 3 PRONG ATTACHMENT TUBE THAT WAS ABLE TO BE REMOVED. IT WAS CONFIRMED THAT THE SPIKE ON THE LINE THAT WAS ATTACHED TO THE PRONGS HAS REMAINED INTACT THEREFORE THE PLASTIC WAS NOT FROM THE LINE. THERE WAS NO MEDICATION IN USE AT THE TIME OF THE EVENT. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244508 43 CM (17") APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 CLAMPS (BLUE, 2 RED), DRY SPIKE STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5970631 00840619098476

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED IV LINE, MFR UNK.