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	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred involving 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.It was reported that the syringe pump set was leaking smof at the valve by the 3-way connector.Although there was patient involvement, there were no adverse events were reported.
Additional Manufacturer Narrative
The device has been requested for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
Received three used list# mc330419, 102" (259 cm) appx 8.2 ml, pur standardbore/smallbore transfer set w/microclave® clear, dual check valve, 1.2 micron filter, luer lock; lot# unknown.No visual damages or anomalies were observed.The reported complaint of a leak could not be confirmed.The returned samples were tested an met product specifications.A dhr lot# review could not be conducted because no lot number(s) was/were identified.D9 - date returned to mfg: 27aug2025.Corrected information can be found in section e (throughout) and g2 - report source.Additional contact information: reporter name: (b)(6).Reporter position/department: product quality, safety reporter phone: n/a.Reporter email: (b)(6).

• 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: 22861613
• Report Number: 9617594-2025-01723
• Device Sequence Number: 18087491
• Product Code: FMG
• UDI-Device Identifier: 00887709087552
• UDI-Public: 00887709087552
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: SMOF, MFR UNK.; SYRINGE PUMP SET, MFR UNK.
• Patient Sex: Unknown