MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC33332
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	01/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The event involved a 128" (325 cm) appx 9.3 ml, transfer set w/microclave clear, dual check valve, smallbore bifuse ext set w/microclave clear (green ring), 0.2 micron filter, rotating luer where the customer reported that the device back flowed into the bag when the patient end of the tubing is clamped.The patient was started on a dextrose secondary infusion and given one dextrose bolus.There was patient involvement and patient experienced low urine output and low glucose levels.The patient was reported to be stable after the event.
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Additional Manufacturer Narrative
Investigation summary: one (1) used, list #mc33332, lot #14553587, connected to the item #z2133 lot #14355524, an unknown bd needleless connector, lot #25065382 and an unknown, bd 50ml syringe were returned for evaluation.As received no physical damage or anomalies only unknown solution residual.The set was tested as returned as per procedure and no backflow through the dual check valves, was noted.However, a leak from the filter vent hole at the spikes and from the filter vent hole as well, was confirmed.Complaint of backflow of fluid was not able to be confirmed or replicated.However, during the test a leak from the filter vent hole was noted, the probable cause is typically due to a temporary or complete loss of hydrophobic properties of the filter vent material due to an infusate interaction during use.Lot history review a device history lot review was performed, finding no relevant commodities, anomalies or nonconformances that might be related with the condition found by customer.

• Brand Name: 128" (325 CM) APPX 9.3 ML, TRANSFER SET W/MICROCLAVE CLEAR, DUAL CHECK VALVE, S
• 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: 24527024
• Report Number: 9617594-2026-00229
• Device Sequence Number: 18252629
• Product Code: FMG
• UDI-Device Identifier: 00887709037816
• UDI-Public: (01)00887709037816(17)300801(10)14553587
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MC33332
• Device Lot Number: 14553587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown