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.It was 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 was no delay in therapy.There was no adverse event.No medication was being used with this product.The product was not reprocessed or re sterilized prior to use.There were no patient involvement and harm.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.E1 - initial reporter phone and email is unknown.

• 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: 50697160
• Report Number: 9617594-2026-01228
• Device Sequence Number: 5915819
• 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: Health Professional,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: 14799598
• 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: 12/04/2025
• 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
• Patient Sex: Unknown