MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.34 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP; STOPCOCK, I.V. SET

Catalog Number	MC33463
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding a 7" (18 cm) appx 0.34 ml, smallbore bifuse ext set w/2 microclave clear, 2 clamps, luer lock where it was reported that the patient had docetaxel infusing and was sitting in chair when luer lock cap snapped off from tubing.Blood backing up from iv site and leaked onto patient's arm, chair and floor.Chemo spill initiated due to blood being mixed with chemo.The event occurred during infusion.There was patient involvement but no reported harm.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.

• Brand Name: 7" (18 CM) APPX 0.34 ML, SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMP
• 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25217399
• Report Number: 9617594-2026-00468
• Device Sequence Number: 15951999
• Product Code: FMG
• UDI-Device Identifier: 00887709039001
• UDI-Public: (01)00887709039001(17)310101(10)14858626
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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: MC33463
• Device Lot Number: 14858626
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 06/12/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2026
• Is the Device Labeled for Single Use? (Y/N): No
• 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: DOCETAXEL, MFR UNKNOWN
• Patient Sex: Unknown