MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 142" (361 cm) 15 Drop Primary Set w/3 MicroClave¿ Clear, Remv 3-Port NanoClave¿; Stopcock, I.V. Set

Catalog Number	AM3111
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Chest Pain (1776); Decreased Respiratory Rate (2485)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A reported incident involved a gravity administration set used with a pressure bag.During preparation for a possible operative delivery, the patient required rapid intravenous fluid administration before epidural placement.The administration set was connected to an iv fluid bag, and the pressure bag.When the nurse returned, the fluid bag was empty and air was observed in the tubing, resulting in suspected administration of air to the patient.The patient subsequently experienced shortness of breath and chest pain, prompting a rapid response and evaluation by cardiology and other clinical teams.The planned procedure was cancelled.The patient reportedly recovered without known lasting harm.There was patient involvement and no harm.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.B3: unknown; no information has been provided to date.

• Brand Name: 142" (361 cm) 15 Drop Primary Set w/3 MicroClave¿ Clear, Remv 3-Port NanoClave¿
• 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: 50734754
• Report Number: 9617594-2026-01250
• Device Sequence Number: 21487882
• Product Code: FMG
• UDI-Device Identifier: 00887709095274
• UDI-Public: (01)00887709095274
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AM3111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Alaris pump.; BD infusion tubing.; BD tubing set.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female