MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) APPX 2.4 ML, EXT SET W/MICROCLAVE®, CHECK VALVE; STOPCOCK, I.V. SET

Catalog Number	CH3557
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, on an unknown date, a 12" (30 cm) appx 2.4 ml, ext set w/microclave¿, check valve generated a leak during patient use.It was reported that the tubing area near the check valve had a small droplet, indicating a breach in the tubing line.The event occurred during the sampling operation.Liquid droplets were observed coming from the tubing area near the filter port, and it was detected on the tubing immediately above the filter connection near the heat-sealed end.No abrasions were observed near the defect.The fracture surfaces are slightly rough ¿ no clear perforation mechanism is apparent, but it does not appear to be consistent with contact by a bladed instrument.No additional leaks were detected in the sample.A sample photo was provided showing the affected products.
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Additional Manufacturer Narrative
One used device was received for evaluation on 8/29/2025.As received, it was noted that the original length set should be 9", however as received the set was shorter than 2", no additional damages were visible noted.The sample was primed and a leak from a tear on the tube was confirmed.Complaint of leaks can be confirmed.The probable cause of the tear observed on the tube is unknown.Lot history review is pending.
Additional Manufacturer Narrative
The device history lot review of the affected product (14303133) was performed and no anomalies, nonconformances were identified that might be related with the condition reported by customer.

• Brand Name: 12" (30 CM) APPX 2.4 ML, EXT SET W/MICROCLAVE®, CHECK VALVE
• 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: 22883070
• Report Number: 9617594-2025-01733
• Device Sequence Number: 21048122
• Product Code: FMG
• UDI-Device Identifier: 00887709076389
• UDI-Public: (01)00887709076389(17)300201(10)14303133
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2025

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: CH3557
• Device Lot Number: 14303133
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 09/09/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/04/2025; 10/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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