MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR (RED, GREEN, YELLOW RINGS),; STOPCOCK, I.V. SET

Catalog Number	MC33318
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be received for evaluation; however, it has not yet been returned.B3 - date of event is unknown; the first date of the month reported has been used as a placeholder.
Event or Problem Description
The event involved a 5" smallbore quadfuse ext set w/4 microclave® clear (red, green, yellow rings), 4 clamps, rotating luer where the customer reported that the nurse assisted patient up and out of bed.When the patient stood up, the quad attachment that was on the purple lumen was found on the floor where cardiac medications were infusing through this port with maintenance intravenous fluids (mivf).The customer stated, "drips were stopped, and pharmacy was called to make gtts stat." the patient's vitals were stable and did not have any change in condition.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Product received date: 2/6/2026.One used device was returned for investigation.During visual inspection, there were no defects or anomalies noted.An icu medical provided male luer was connected to each microclave and leak tested.There was no leakage or issues in connecting to each microclave.The male luer was measured and found to meet iso standards.The reported complaint was unable to be replicated or confirmed.A device history record (dhr) review could not be performed as the lot number was unknown.

• Brand Name: 5" SMALLBORE QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR (RED, GREEN, YELLOW RINGS),
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23979391
• Report Number: 9617594-2026-00008
• Device Sequence Number: 13437733
• Product Code: FMG
• UDI-Device Identifier: 00887709037717
• UDI-Public: 00887709037717
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC33318
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2025
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARDIAC MEDICATIONS AND MIVF, MFR UNK.
• Patient Sex: Unknown