MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" (259 CM) APPX 5.0 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE, S; STOPCOCK, I.V. SET

Catalog Number	MC330583
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
A complaint was received regarding the 102" (259 cm) appx 5.0 ml, transfer set w/microclave¿ clear, dual check valve, smallbore trifuse ext set w/2 microclave¿ clear, 0.2 micron filter, clamp, rotating luer that experienced leakage.It was reported that the product was leaking on two occasions.A sample photo was provided showing the affected product.There was unknown patient involvement.
Additional Manufacturer Narrative
Investigation summary: received the following: one (1) used.List #mc330583, 102" (259 cm) appx 5.0 ml, transfer set w/microclave¿ clear, dual check valve, smallbore trifuse ext set w/2 microclave¿ clear, 0.2 micron filter, clamp, rotating luer; lot #14271059.Two (2) used.List #unknown, extension tubing with clave; lot #unknown.One (1) used.List #unknown, edwards transducer; lot #unknown.One (1) used.List #unknown, microclave; lot #unknown.One (1) used.List #unknown, stopcock; lot #unknown.One (1) used.List #unknown, microclave; lot #unknown.One (1) used.Extension tubing with microclave and filter; lot #unknown.One (1) used.List #unknown, bifuse device; lot #unknown.Two (2) used.List #unknown, microclave; lot #unknown.Two (2) used.List #unknown, extension tubing with microclave; lot #unknown.One (1) used.List #mc330583, 102" (259 cm) appx 5.0 ml, transfer set w/microclave¿ clear, dual check valve, smallbore trifuse ext set w/2 microclave¿ clear, 0.2 micron filter, clamp, rotating luer; lot #14271059.One (1) used.List #unknown, extension tubing with microclave and filter; lot #unknown.One (1) used.List #unknown, bifuse device; lot #unknown.Two (2) used.List #unknown, microclaves; lot #unknown.Two (2) used.List #unknown, extension tubing with microclaves; lot #unknown.No visual damages or anomalies were observed on any sample.The reported complaint of a leak could be confirmed.The returned samples were tested an a leak was observed on the inline filter.The probable cause of the leak is from the temporary loss of hydrophobic properties.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 102" (259 CM) APPX 5.0 ML, TRANSFER SET W/MICROCLAVE¿ CLEAR, DUAL CHECK VALVE, S
• 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: 22102453
• Report Number: 9617594-2025-01118
• Device Sequence Number: 8232938
• Product Code: FMG
• UDI-Device Identifier: 00887709095861
• UDI-Public: (01)00887709095861(17)300101(10)14271059
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: MC330583
• Device Lot Number: 14271059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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
• Patient Sex: Unknown