MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) EXT SET W/1.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1115
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding a 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer where it was reported that two separate alaris lipid filters were found cracked at the luer lock attachment site.Both filters were removed from the iv tubing, and the tubing was re-primed with new filters.The patient involved in the event was a 9-year-old male with initials c.B., weighing 5.6 kg, and identified as black or african american.There were a patient involvement and no harm reported.
Additional Manufacturer Narrative
Investigation summary the reported complaint of a broken luer could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed, and a probable cause cannot be determined.No lot received for a device history review.

• Brand Name: 12" (30 CM) EXT SET W/1.2 MICRON FILTER, 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.
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24832840
• Report Number: 9617594-2026-00360
• Device Sequence Number: 10447103
• Product Code: FMG
• UDI-Device Identifier: 00840619045524
• UDI-Public: 00840619045524
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: B1115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ALARIS LIPID FILTERS
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Race: Black Or African American