MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 126" (320 CM) APPX 22.4 ML, 15 DROP ADMIN SET W/4 CLAVE¿, SPIN LUER, 1 EXT, DROP; STOPCOCK, I.V. SET

Catalog Number	B33955
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a drop admin set w/4 clave, spin luer and it was reported that intravenous (iv) tubing sets were leaking.There was no reported patient involvement, and no reported patient harm.
Additional Manufacturer Narrative
Investigation summary: the reported complaint of a leak could be confirmed from the photos provided.However, without the return of the sample a comprehensive review cannot be performed and a probable cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 126" (320 CM) APPX 22.4 ML, 15 DROP ADMIN SET W/4 CLAVE¿, SPIN LUER, 1 EXT, DROP
• 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: 24320746
• Report Number: 9617594-2026-00119
• Device Sequence Number: 9423422
• Product Code: FMG
• UDI-Device Identifier: 00887709124493
• UDI-Public: (01)00887709124493(17)301001(10)14640563
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 03/30/2026

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: B33955
• Device Lot Number: 14640563
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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 Sex: Unknown