MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.80 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, 0.2 MICRO; STOPCOCK, I.V. SET

Catalog Number	MC33425
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following device: 60" (152 cm) appx 0.80 ml, smallbore ext set w/remv microclave® clear, 0.2 micron filter, clamp, luer lock reportedly leaked at the filter location.The line was infusing rifampin.Leakage was noticed while flushing the line with normal saline.There was no report of any human harm.
Additional Manufacturer Narrative
The reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.The device history record could not be reviewed because the lot number is unknown.

• Brand Name: 60" (152 CM) APPX 0.80 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, 0.2 MICRO
• 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: 25281119
• Report Number: 9617594-2026-00500
• Device Sequence Number: 13203098
• Product Code: FMG
• UDI-Device Identifier: 00887709038684
• UDI-Public: 00887709038684
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: MC33425
• Device Lot Number: UNKNOWN
• 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: 05/01/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NORMAL SALINE, MFR UNK; RIFAMPIN, MFR UNK
• Patient Sex: Unknown