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	04/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a cracked filter and leak 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 (dhr) review.
Event or Problem Description
An email was received regarding a 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer, alleging that the lipid filter was cracked and the patient had trifuse with lipids in one port and central venous pressure (cvp) in a second port.Lipids were backflowing into the pressure tubing of the cvp transducer at the trifuse.The cvp transducer was changed but ther was no improvement to the trifuse was changed and no improvement.A crack was identified in the plastic connecting the filter to the trifuse, so lipids were backflowing into the transducer due to the increased pressure.Several accesses to line with increased risk for clabsi, new lipids were ordered and primed through the new filter/tubing.The event occurred during infusion, and the patient is female with initial sh born on 24th february 2026, weighing 6kg.There was a patient involvement and no harm.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25119264
• Report Number: 9617594-2026-00439
• Device Sequence Number: 10339068
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: NO INFORMATION
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 05/07/2026
• 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: LIPIDS, UNK MFR.
• Patient Age: 1 MO
• Patient Sex: Female
• Patient Weight: 6 KG