MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" BIFUSE EXT SET, 2 CLAVE¿, 2 CLAMPS, LUER LOCK; STOPCOCK, IV. SET.

Catalog Number	20710-01
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event was reported via user facility mandatory medwatch report number (b)(4).It was reported that two instances occurred on an unspecified date in (b)(6) 2025, (b)(6) 2025 is being used as placeholder.The events involved 8" bifuse ext set, 2 clave¿, 2 clamps, luer lock where the customer reported that the nurse noted that the patient's y-extension iv tubing had come apart.The y-tubing has 2 "tails", and each tail has a hub attached to connect iv fluids or give iv push medications.One of the hubs had disconnected from the tubing, as if it were just pushed onto the tubing.Customer stated that usually this tubing is permanently connected and is not detachable.The tubing was replaced with a new y-tubing set, and it happened again.The event occurred in the hospital.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.
Additional Manufacturer Narrative
The medwatch number was cited in b5 of the initial mdr but omitted from h10, and that this follow up is to add it.

• Brand Name: 8" BIFUSE EXT SET, 2 CLAVE¿, 2 CLAMPS, LUER LOCK
• Common Device Name: STOPCOCK, IV. 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: 23610456
• Report Number: 9617594-2025-02198
• Device Sequence Number: 21133014
• Product Code: FMG
• UDI-Device Identifier: 00887709005730
• UDI-Public: 00887709005730
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 20710-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/16/2025
• 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
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic