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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation; a device history will be reviewed.
Event or Problem Description
The event involved a 12" (30 cm) ext set w/1.2 micron filter, clamp, rotating luer where the customer reported that the device leaked at the filter during patient use.There was patient involvement, a delay in therapy and the patient required a blood transfusion.Additional information is being requested.The exact date of the event is unknown.
Additional Manufacturer Narrative
Investigation summary one (1) used sample list #b1115, 12" was returned for evaluation.As returned the tube was separated from the filter port on the filter.Both components were observed through uv light and no solvent marks were observed.The outer diameter of the separated tube was measured and is within specification.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Complaint of leaking is confirmed from the returned sample evaluation.The probable cause is due to an insufficient solvent applied during manual process assembly in ensenada.

• 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: 21368246
• Report Number: 9617594-2025-00275
• Device Sequence Number: 15562917
• Product Code: FMG
• UDI-Device Identifier: 00887709095854
• UDI-Public: (01)00887709095854(17)20280501(10)13623704
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: B1115
• Device Lot Number: 13623704
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown