MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®; STOPCOCK, I.V. SET

Catalog Number	MC330419
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 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 4-way connector leaking at filter and standard concentration tubing leaking at filter ("aads" line).There was no reported patient involvement.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.Additional reporter information: (b)(6).
Additional Manufacturer Narrative
D9 - device available for evaluation: no additional information included in b5.
Event or Problem Description
Additional information received stating that there was patient involvement but no patient harm.
Additional Manufacturer Narrative
The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history lot number was reviewed, and no nonconformities were found that would have led to the reported complaint.Updated information in d9.

• Brand Name: 102" (259 CM) APPX 8.2 ML, PUR STANDARDBORE/SMALLBORE TRANSFER SET W/MICROCLAVE®
• 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: 23628063
• Report Number: 9617594-2025-02209
• Device Sequence Number: 18761397
• Product Code: FMG
• UDI-Device Identifier: 00887709087552
• UDI-Public: (01)00887709087552(17)300601(10)14469374
• 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): 01/02/2026

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: MC330419
• Device Lot Number: 14469374
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/16/2025; 12/23/2025
• Initial Report FDA Received Date: 11/23/2025
• Supplement Report FDA Received Date: 12/18/2025; 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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: AADS LINE, UNK MFR.
• Patient Sex: Unknown