MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	MC9013
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An email was received regarding 14" ext set w/0.2 micron filter, clave clear, clamp, rotating luer in which it was reported that the patient was on a large amount of pressors, and the blood pressure dropped due to no flow.The initial reporter stated: the plan was to wait for family to change goc [abbreviation not specified].Registered nurse noted that the line was backing up with blood past the filter and patient's blood pressure was dropping.Registered nurse replaced the stop cock, and the extension tubing (with filter) and the patient's blood pressure was improved.Registered nurse noticed a piece of plastic stuck in the stop cock that presumably broke off the extension set two devices.The event occurred during infusion.There was a patient involvement and no harm.
Additional Manufacturer Narrative
E1.Additional contacts: (b)(6).The device has been requested for evaluation- it has not been received.The investigation is pending.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25153503
• Report Number: 9617594-2026-00448
• Device Sequence Number: 10752294
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: 00887709039391
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2026

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: MC9013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/12/2026
• Supplement Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: UNKNOWN BLOOD PRESSURE DRUG, MFR UNKNOWN.
• Patient Sex: Unknown