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	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An event involved a 102" (259 cm) appx 8.3 ml ext set bifuse pur standardbore/smallbore w/clave¿ clear, spiros¿ w/red cap, dual check valve, 1.2 micron filter, luer lock reported that the 1.2-micron filter was leaking on iv(intravenous) tubing parental solution.The sets failed multiple times.There was patient involvement and no reported patient harm.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.
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 reviewed, and no nonconformities were found that would have led to the reported complaint.Updated information in d9 - device available for evaluation, d9 - date returned to mfg null.

• 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: 23886850
• Report Number: 9617594-2025-02329
• Device Sequence Number: 4669433
• Product Code: FMG
• UDI-Device Identifier: 00887709127364
• UDI-Public: (01)00887709127364(17)300901(10)14613656
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 14613656
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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: PARENTERAL SOLUTION, UNK MFR.
• Patient Sex: Unknown