MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	206680490
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of no flow / can't prime / difficult to prime on clave cannot be confirmed.Since 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 probable cause cannot be determined.
Event or Problem Description
The event occurred on an unknown date involving a extension set, 17 inch, 0.2 micron filter, clave(tm) y-site, secure lock where it was reported that patients are not receiving their iv fluid administered through medfusion 4000iv pumps using icu medical tubing.The status of the product at the time of event was during use on a patient.Patients all experienced decreased urine output and low blood glucose levels.

• Brand Name: EXTENSION SET, 17 INCH, 0.2 MICRON FILTER, CLAVE(TM) Y-SITE, SECURE LOCK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23283683
• Report Number: 9617594-2025-01975
• Device Sequence Number: 20213729
• Product Code: FPA
• UDI-Device Identifier: 10887787005919
• UDI-Public: (01)10887787005919
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K151969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

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: 206680490
• 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: 09/15/2025
• Initial Report FDA Received Date: 10/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEDFUSION 4000 IV PUMPS; UNSPECIFIED IV FLUID, MFR UNK
• Patient Sex: Unknown