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	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.
Event or Problem Description
The event involved a 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 where it was reported the product was leaking total parenteral nutrition (tpn).There was unknown patient involvement and unknown human harm.
Additional Manufacturer Narrative
D9 - date returned to mfg: 5 may 2025.Investigation summary: received a photo of the sample from the customer showing where the leak occurred.No conclusions could be made from the photo.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 device history record lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the 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: 22096909
• Report Number: 9617594-2025-01110
• Device Sequence Number: 6925961
• 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): 07/11/2025

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?: No
• 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: 06/13/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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: TOTAL PARENTERAL NUTRITION, UNK MFR.
• Patient Sex: Unknown