MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 129" (328 CM) APPX 24.3 ML 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, 4-WAY STOPCOCK, 3; STOPCOCK, I.V. SET

Catalog Number	AM3130
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the complaint of product incorporates / allows air passage on item am3130 cannot be confirmed.Since 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 probable cause cannot be determined.The device history record was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.
Event or Problem Description
Event occurred regarding a 129" (328 cm) appx 24.3 ml 15 drop admin set w/3 clave¿ clear, 4-way stopcock, 3 check valves, 3-port nanoclave¿ manifold, spin luer, 2 ext where the report stated that "the line was clamped with the roller clamp, and the stop cock was turned to off.The ivf continued to drip and run dry, pulling a large air bubble extending the length of the tubing." there was patient involvement, but no harm was caused by the incident.

• Brand Name: 129" (328 CM) APPX 24.3 ML 15 DROP ADMIN SET W/3 CLAVE¿ CLEAR, 4-WAY STOPCOCK, 3
• 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: 22929112
• Report Number: 9617594-2025-01777
• Device Sequence Number: 16008248
• Product Code: FMG
• UDI-Device Identifier: 00887709128224
• UDI-Public: (01)00887709128224(17)300601(10)14447574
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2025

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: AM3130
• Device Lot Number: 14447574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IV INFUSION UNKNOWN
• Patient Sex: Unknown