MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 72" (183 CM) APPX 2.1ML, SMALLBORE EXT SET W/CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B2011
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation, however, a lot history review will be performed.E1 - telephone number was provided as (b)(6).
Event or Problem Description
The event involved a 72" (183 cm) appx 2.1ml, smallbore ext set w/clamp, rotating luer where the customer reported that propofol squirted in the doctor's eye as he was pushing it through the tubing for the patient.There is a small hole in one end that connects to the syringe.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.The device history review lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.

• Brand Name: 72" (183 CM) APPX 2.1ML, 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: 23621899
• Report Number: 9617594-2025-02206
• Device Sequence Number: 9032313
• Product Code: FMG
• UDI-Device Identifier: 00887709002890
• UDI-Public: (01)00887709002890(17)291201(10)14232176
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: B2011
• Device Lot Number: 14232176
• 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: 11/10/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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: PROPOFOL, MFR UNK.
• Patient Sex: Unknown