MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 0.4 ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B2003
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 60" (152 cm) appx 0.4 ml, smallbore ext set w/clamp, rotating luer where it was reported there was resistance encountered when used in conjunction with the syringe pump.This resulted in a delay in administration due to the blocking, personnel are then required to inject manually.The event occurred during infusion; however, no harm was reported.
Additional Manufacturer Narrative
The device is not available for evaluation; however, a lot number has been provided.A device history lot review is pending.Additional reporter: (b)(6).
Additional Manufacturer Narrative
Investigation summary: no b2003 product samples, videos or photographs were returned for investigation.The device history record was reviewed and there were no non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: 60" (152 CM) APPX 0.4 ML, SMALLBORE EXT SET W/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: 22185386
• Report Number: 9617594-2025-01199
• Device Sequence Number: 8570096
• Product Code: FMG
• UDI-Device Identifier: 00887709002838
• UDI-Public: (01)00887709002838(17)290701(10)14092716
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: B2003
• Device Lot Number: 14092716
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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: SYRINGE PUMP, UNK MFR
• Patient Sex: Unknown