MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 120" (305 cm) Appx 15.8 ml, 15 Drop Admin Set w/3 Clave¿ Clear, NanoClave¿ Stopc; Stopcock, I.V. Set

Catalog Number	AC135
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 120" (305 cm) appx 15.8 ml, 15 drop admin set w/3 clave¿ clear, nanoclave¿ stopcock, 2 check valves, spin luer, 2 ext it was reported that when the nurse spiked a bag and the tubing wouldn't prime.The nurse used 2 more sets of tubing.The tubing primed the next time however the fluid would not drip once connected to the patient.No noted visible damage or defects.The fluid administered was lactated ringers.The event occurred during patient use.There was a patient involvement but no reported patient harm.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.

• Brand Name: 120" (305 cm) Appx 15.8 ml, 15 Drop Admin Set w/3 Clave¿ Clear, NanoClave¿ Stopc
• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50064634
• Report Number: 9617594-2026-00953
• Device Sequence Number: 10480690
• Product Code: FMG
• UDI-Device Identifier: 00887709124417
• UDI-Public: (01)00887709124417(17)310401(10)14868636
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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
• Report Date (Section B): 07/29/2026

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: AC135
• Device Lot Number: 14868636
• 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: 07/10/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2026
• 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