MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 100" (254 CM) APPX 4.6 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE, R; STOPCOCK, I.V. SET

Catalog Number	MC330584
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of no flow / can't prime / difficult to prime on mc330584 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.
Event or Problem Description
The event occurred on unknown various dates involving a 100" (254 cm) appx 4.6 ml, transfer set w/microclave¿ clear, dual check valve, rotating luer where it was reported that patients were not receiving their iv fluid administered through medinfusion 4000iv pumps using icu medical tubing.The status of the product at the time of event was during use on a patient.Patients all experienced decreased urine output and low blood glucose levels.This report captures 2 occurrences.
Additional Manufacturer Narrative
D9 - date returned to mfr: 11/4/2025.Received one (1) new mc330584 transfer set w/microclave, one (1) new 20668-28 extension set, one (1) new 12120 smallbore bifuse ext set/2 clave, and one (1) new bd 10 ml syringe for inspection.The mc330584 and mating devices were connected and attached to an iv bag.Fluid was withdrawn into the bd 10 ml syringe and infused.There were no restrictions in flow.The reported complaint was unable to be confirmed.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed for the possible lot numbers and received lot number, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 100" (254 CM) APPX 4.6 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE, R
• 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: 23281128
• Report Number: 9617594-2025-01973
• Device Sequence Number: 15655687
• Product Code: FMG
• UDI-Device Identifier: 00887709095878
• UDI-Public: (01)00887709095878
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: MC330584
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 04/17/2026
• 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: MEDFUSION 4000 IV PUMPS.
• Patient Sex: Unknown