MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 5 CLAMPS (3 WHITE, 1 BLUE, 1 RED), R; STOPCOCK, I.V. SET

Catalog Number	MC330360
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One photo was shared by the customer, showing the male luer as disconnected from the tube.An unknown residual was observed around the plastic bag.No additional damage or anomalies were observed from the provided photograph.The customer also provided the following for investigation: one used list #mc330360.As received, the male luer was separated from the tubing.The tube and the male luer were analyzed with a uv light and an insufficient present of solvent on both component was found.The od of the separated tube and id of the male luer were measured finding within specification.The customer complaint was confirmed.The probable cause was insufficient solvent applied during the manufacturing assembly process.A dhr review could not be conducted because no lot number was identified.
Event or Problem Description
The complaint was against a 10" quadfuse ext set w/4 microclave® clear, 5 clamps (3 white, 1 blue, 1 red), rotating luer.The report stated that the luer connection disconnected from the tubing on a set during patient use.This happened twice in 24 hours for same patient.There was mild patient harm (a small amount of blood loss) both times.This emdr reflects two similar occurrences.

• Brand Name: 10" QUADFUSE EXT SET W/4 MICROCLAVE® CLEAR, 5 CLAMPS (3 WHITE, 1 BLUE, 1 RED), R
• 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: 22354850
• Report Number: 9617594-2025-01383
• Device Sequence Number: 18298115
• Product Code: FMG
• UDI-Device Identifier: 00887709085299
• UDI-Public: 00887709085299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/29/2025

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: MC330360
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/30/2025
• 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
• Patient Sex: Unknown