MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 100" (254 CM) APPX 12.3 ML, 15 DROP ADMIN SET W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B30010
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation, however a device history review should be conducted.
Event or Problem Description
The event occurred on an unspecified date and involved a 100" (254 cm) appx 12.3 ml, 15 drop admin set w/rotating luer where the customer reported that during routine clinical use, in a veterinary clinic, it was observed that macrodrip lines continue to free-flow even when the pump door is fully closed and the pump is operating.Harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Additional information: customer clarified: there was no human patient involvement.It is an animal clinic.B3 - date of event - updated.Investigation summary: the complaint could not be confirmed by investigation.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 a cause cannot be determined.The device history was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 100" (254 CM) APPX 12.3 ML, 15 DROP ADMIN SET W/ROTATING LUER
• 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: 24521212
• Report Number: 9617594-2026-00224
• Device Sequence Number: 13184651
• Product Code: FMG
• UDI-Device Identifier: 00887709003934
• UDI-Public: (01)00887709003934(17)300801(10)14526196
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: B30010
• Device Lot Number: 14526196
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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
• Patient Sex: Unknown