MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 100" (254 cm) Appx 12.3 ml, 15 Drop Admin Set w/Rotating Luer; Stopcock, I.V. Set

Catalog Number	B30010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 100 inch (254 cm) appx 12.3 ml, 15 drop admin set w rotating luer reported that customer advised that when priming this set, the y-sites were leaking fluid.After further discussion, customer indicated that the fluid in use was heparinized, pressurized saline.The product was not contaminated or contain a biohazard or chemotherapy agent.There were no patient involvement and harm.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.

• Brand Name: 100" (254 cm) Appx 12.3 ml, 15 Drop Admin Set w/Rotating Luer
• 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: 50694864
• Report Number: 9617594-2026-01220
• Device Sequence Number: 15874395
• Product Code: FMG
• UDI-Device Identifier: 00887709003934
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: B30010
• Device Lot Number: 13960812
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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
• Patient Sex: Unknown