MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave®, Clamp, Rotating Luer; stopcock, i.v. set

Catalog Number	011-C3302
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a smallbore ext set with microclave.It was reported that there was leakage from the clave.The issue was noted during priming.There were no concomitant drug and concomitant device involved.There was no bleedback, no biohazard, no user facility medwatch, and no chemo.The device was not reprocessed or resterilized.The quantity affected is 2, and the sample is available for return.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.E1 - (b)(6).Customer: (b)(6).Address: (b)(6).

• Brand Name: 7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave®, Clamp, Rotating Luer
• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50805603
• Report Number: 9617594-2026-01292
• Device Sequence Number: 18789053
• Product Code: FMG
• UDI-Device Identifier: 00840619001537
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: TW
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 011-C3302
• Device Lot Number: 14237095
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2024
• 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