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	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Event or Problem Description
The event occurred on an unspecified date and 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 stated in the report that the line seemed to prime fine but then flow stopped when it was connected to iv.It could have also been related to the lower backcheck valve not fully ¿popping¿ open.There was unknown patient involvement, unknown patient harm and unknown delay in therapy.
Additional Manufacturer Narrative
Received one used ac135 admin set for inspection.No defects or anomalies noted.No errant solvent observed on the check valves.The sample was primed by hanging from an icu medical provided iv bag.There were no restrictions in flow.The reported complaint was unable to be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22054922
• Report Number: 9617594-2025-01057
• Device Sequence Number: 15219401
• Product Code: FMG
• UDI-Device Identifier: 00887709124417
• UDI-Public: (01)00887709124417(17)290901(10)14144071
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 14144071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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: UNSPECIFIED IV, UNK MFR
• Patient Sex: Unknown