BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14" (36 CM) APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RE

    MDR report key: 17209800 · Received June 27, 2023

    Report

    Report Number
    9617594-2023-00273
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    May 30, 2023
    Report Date
    May 31, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619024949
    PMA / PMN Number
    K082836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COUPLE OF PHOTOS WERE SHARED BY THE CUSTOMER, IN ALL OF THEM A SMALL PLASTIC PARTICULATE FLOATING INSIDE THE DRIP CHAMBER WAS OBSERVED, AND NO ADDITIONAL DAMAGE OR ANOMALY WAS OBSERVED IN THE PHOTOS.ONE (1) USED SAMPLE #011-CH3142 CONNECTED INTO A 0.9% SODIUM CHLORIDE 500ML BAG AND AN UNKNOWN, EXTENSION SET W/ DRIP CHAMBER WERE RETURNED FOR EVALUATION, AS RECEIVED IT WAS OBSERVED INSIDE THE DRY SPIKE ADAPTOR A FLASH CONDITION (EXCESS OF PLASTIC). THE SET WAS TESTED USING A FILTRATION SYSTEM TO FILTER THE FLUID AND NO DEBRIS WAS OBSERVED. HOWEVER, INSIDE THE DRIP CHAMBER, A SMALL WHITE PARTICULATE WAS FLOATING.COMPLAINTS OF PARTICULATE MATTER CAN BE CONFIRMED BASED ON THE PHOTOS AND THE PHYSICAL SAMPLE RETURNED BY THE CUSTOMER. THE PROBABLE CAUSE OF THE EXCESS OF PLASTIC INSIDE THE DRY SPIKE ADAPTOR WAS AN ERROR DURING THE MOLDING PROCESS FROM ENSENADA'S SUPPLIER.A DEVICE HISTORY REVIEW (DHR) COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.ADDITIONAL INFORMATION D9: PRODUCT RECEIVED 8/8/2023G1: REED COVERT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 14" (36 CM) APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RED), DRY SPIKE ADAPTER "AFTER NURSES PREPARE THEIR LINES BY ATTACHING CH3142 SPIKE TO SALINE, THEN ATTACHING INTRAVENOUS (IV) LINE, WHEN PRIMING SALINE, PLASTIC IS NOTED WITHIN IV LINE CHAMBER. WHEN UN-SPIKING THE IV LINE, PLASTIC WAS NOTED TO BE SEEN IN THE SPIKE HOLE AT THE BASE OF THE SPIKE. WITH IV LINE SPIKE INTACT. THERE WAS NO MEDICATION BEING USED WITH THIS PRODUCT. THE PRODUCT IS NOT CONTAMINATED OR CONTAINS A BIOHAZARD OR CHEMOTHERAPEUTIC AGENT. THAT THE EVENT OCCURRED DURING PRIMING. NOBODY WAS HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541623 14" (36 CM) APPX 6.9 ML, TRIFUSE ADD-ON SET W/3 BAG SPIKES, 3 CLAMPS (BLUE, 2 RE STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5870799 00840619024949

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown VLON72, UKN MFR| VLSP90, UNK MFR| VLST02 UKN MFR| VLTR42, UNK MFR