MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLE; STOPCOCK, I.V. SET

Catalog Number	MC330716
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available for return.The device evaluation will proceed with the available information with results sent in final report.
Event or Problem Description
An event involved a 102" (259 cm) appx 8.3 ml ext set bifuse pur standard bore/smallbore w/clave¿ clear, spiros¿ w/red cap, dual check valve, 1.2 micron filter, luer lock where it was reported that the filter in antiarrhythmic drugs (aads) standard concentration tubing leaking.The line was changed.There was unknown patient involvement, and no reported patient harm.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review was conducted, and no nonconformities were found that would have led to the reported complaint.Updated information in b5 and concomitant products field.
Event or Problem Description
Additional information was received where the customer confirmed that the aads that was used during the reported issue was amino acids dextrose solution and there was patient involvement, and no patient harm reported.

• Brand Name: 102" (259 CM) APPX 8.3 ML EXT SET BIFUSE PUR STANDARDBORE/SMALLBORE W/CLAVE¿ CLE
• 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: 24542668
• Report Number: 9617594-2026-00237
• Device Sequence Number: 9194016
• Product Code: FMG
• UDI-Device Identifier: 00887709127364
• UDI-Public: (01)00887709127364(17)300501(10)14425342
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: MC330716
• Device Lot Number: 14425342
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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: AMINO ACIDS DEXTROSE SOLUTION, UNK MFR.
• Patient Sex: Unknown