BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    113" (287 CM) APPX 21.2 ML, 10 DROP PRIMARY SET W/2 CLAVE® CLEAR, ROTATING LUER

    MDR report key: 25031786 · Received April 29, 2026

    Report

    Report Number
    9617594-2026-00417
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00887709057654
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR RETURN; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    A '113" (287 CM) APPX 21.2 ML, 10 DROP PRIMARY SET W/2 CLAVE® CLEAR, ROTATING LUER' REPORTEDLY HAD PINHOLE LEAKAGE AT 1:00 PM ON THE DAY OF THE EVENT. DUE TO THIS ISSUE, THE PATIENT DID NOT RECEIVE HIS FULL RENFLEXIS (INFLIXIMAB) INFUSION. AT THE 1HR 30MINS MARK, THE NURSE WENT TO INCREASE THE IV DRIP RATE TO 250ML PER HOUR; HOWEVER, THE MEDICATION BAG WAS FOUND TO BE EMPTY. BELOW THE IV BAG AND TUBING, THERE WAS A SMALL PUDDLE ON THE FLOOR. ESTIMATED AMOUNT OF FLUID WAS 10ML. THE DRIP "REGULATOR" (ROLLER CLAMP) WAS ADJUSTED THROUGHOUT THE INFUSION CORRECTLY. THE NURSE DEEMED THE VOLUME OF MEDICATION FOUND ON THE FLOOR TO BE NEGLIGIBLE". GIVEN THE MINIMAL VOLUME INVOLVED, THE NURSE DETERMINED THAT NO MEDICATION REPLACEMENT OR TOP-UP WAS REQUIRED. THE PATIENT IS ALSO ON METHOTREXATE, 4 TABLETS WEEKLY. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557834 113" (287 CM) APPX 21.2 ML, 10 DROP PRIMARY SET W/2 CLAVE® CLEAR, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14604075 00887709057654

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male IV BAG CONTAINING RENFLEXIS (INFLIXIMAB), MFR UNK