MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 102" 10 DROP PRIMARY SET W/2 CLAVE®, REMV 3 GANG 4-WAY STOPCOCKS, 3 MICROCLAVE®; STOPCOCK, I.V. SET

Catalog Number	Z2587
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The following medical device '102" 10 drop primary set w/2 clave®, remv 3 gang 4-way stopcocks, 3 microclave®, rotating luer, 2 ext' reportedly leaked unspecified anesthesia on an unspecified date.There was no report of any human harm.
Additional Manufacturer Narrative
Although multiple attempts were made to obtain the device, it is not available for testing at this time.The complaint investigation is pending.

• Brand Name: 102" 10 DROP PRIMARY SET W/2 CLAVE®, REMV 3 GANG 4-WAY STOPCOCKS, 3 MICROCLAVE®
• 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: 25033033
• Report Number: 9617594-2026-00418
• Device Sequence Number: 10133698
• Product Code: FMG
• UDI-Device Identifier: 00887709027008
• UDI-Public: 00887709027008
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: Z2587
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: UNSPECIFIED ANESTHESIA, MFR UNK.
• Patient Sex: Unknown