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	11/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved 102" (259 cm) appx 8.2 ml, pur standardbore/smallbore transfer set w/microclave clear, dual check valve, 1.2 micron filter, luer lock and it was reported that the "aads" line filter leaking.Able to change out line as 2-piece setup was used and no interruption to infusion.There was patient involvement, and no patient harm.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.D4: only di provided as lot number is unknown.Additional contact information: (b)(6).
Additional Manufacturer Narrative
D9 and d10 - updated.The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The dhr (device history record) review couldn't be performed due to the lot number for this complaint was unknown.
Additional Manufacturer Narrative
Correction: h6 - annex code c corrected.

• 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: 23799908
• Report Number: 9617594-2025-02304
• Device Sequence Number: 9389775
• Product Code: FMG
• UDI-Device Identifier: 00887709127364
• UDI-Public: 00887709127364
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/25/2026

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: UNKNOWN
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 02/25/2026; 02/25/2026
• Initial Report FDA Received Date: 12/14/2025
• Supplement Report FDA Received Date: 03/16/2026; 03/25/2026
• 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: "AADS", UNK MFR.
• Patient Sex: Unknown