MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 122" (310 CM) APPX 3.5 ML, EXT SET, SMALLBORE W/CLAVE¿, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	B33971
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dhr could not be reviewed due to the unknown lot number.The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The event occurred regarding a 122" (310 cm) appx 3.5 ml, ext set, smallbore w/clave¿, luer lock reported that bivalrudin infusion tubing found disconnected from trifuse closest to patient.Tubing & medication syringe discarded and reprimed with fresh medication.There were patient involvement and no patient harm.

• Brand Name: 122" (310 CM) APPX 3.5 ML, EXT SET, SMALLBORE W/CLAVE¿, LUER LOCK
• 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: 25394406
• Report Number: 9617594-2026-00531
• Device Sequence Number: 14762536
• Product Code: FMG
• UDI-Device Identifier: 00887709122437
• UDI-Public: 00887709122437
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

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: B33971
• 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: 05/07/2026
• Initial Report FDA Received Date: 06/04/2026
• 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: BIVALIRUDIN
• Patient Age: 4 MO
• Patient Sex: Male
• Patient Weight: 5 KG