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	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Additional used device has been received for the investigation, and the event involved a 120" (305 cm) appx 15.8 ml, 15 drop admin set with 3 clave clear, nanoclave stopcock, 2 check valves, spin luer, 2 ext.It was reported that set was primed successfully but would not deliver fluid when connected to the patient¿s catheter.Saline was involved.There was no delay in therapy because another set was promptly primed and used.There was patient involvement and no patient harm was reported.
Additional Manufacturer Narrative
One used device was returned for evaluation.As received, no physical damage or other anomalies were observed on the returned sample.The set and each of the ports were primed according to procedure, and no occlusions or other anomalies were observed along the device.The reported condition of no flow, inability to prime, or difficulty priming could not be confirmed or replicated based on the physical sample evaluation.

• 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 ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50936640
• Report Number: 9617594-2026-01367
• Device Sequence Number: 9509282
• Product Code: FMG
• UDI-Device Identifier: 00887709124417
• Combination Product (Y/N): N
• 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): 09/29/2026

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: 14991102
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2026
• 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