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	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is received for evaluation; however, it's not been completed.A supplemental mdr will be submitted if any updates become available.
Event or Problem Description
The event involved a '102" 10 drop primary set w/2 clave®, remv 3 gang 4-way stopcocks, 3 microclave®, rotating luer, 2 ext that one tubing has black speck in the drip chamber, the other set had the speck in the drip chamber.At some point, the speck was no longer visible in the drip chamber or visible areas of tubing in the second set.The concern was migration of the particle into an area of tubing that was not visible.There were several portions of tubing that were not visible or were obscured, the event occurred while performing visual inspection, there was no patient involvement and no patient harm.

• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25437146
• Report Number: 9617594-2026-00548
• Device Sequence Number: 10284177
• Product Code: FMG
• UDI-Device Identifier: 00887709027008
• UDI-Public: (01)00887709027008(17)301201(10)14817644
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 07/09/2026

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: 14817644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2026
• 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