MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 10" (25 CM) APPX 2.6 ML, EXT SET, QUADFUSE W/3 CLAVE¿ CLEAR, CHEMOLOCK¿ PORT, 5; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL4180
Medical Device Problem Codes	Fluid/Blood Leak (1250); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 10" (25 cm) appx 2.6 ml, ext set, quadfuse w/3 clave¿ clear, chemolock¿ port, 5 clamps (3 white, 1 blue, 1 red), luer lock where the customer reported that they have had incident reports of quadfuse breaking off from the luer connection.All the breaks happened where the male luer lock inserts into the patient¿s microclave cap.This resulted in blood loss and ivf loss for the patients, chemo spills, and can potentially cause great harm for the patients.The customer stated that there were many incidences of broken equipment but they are unable to give accurate information about which broken extension tubing (bi/tri/quad fuse) had harm; the customer further stated that most did have some harm in blood loss but the volume of blood loss was not able to be obtained.The customer stated that the majority of the blood loss was not substantial enough to require blood transfusion.There may have been some chemo exposure, but none required emergent care or treatment.Should additional information become available, a follow up report will be submitted.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A device history review could not be completed due to the unknown lot number.
Additional Manufacturer Narrative
The device was not returned fore valuation.Two photos were provided; the photos confirm the complaint of the quadfuse breaking off from the luer connection.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Lot history review was not conducted as no lot information was provided.

• Brand Name: 10" (25 CM) APPX 2.6 ML, EXT SET, QUADFUSE W/3 CLAVE¿ CLEAR, CHEMOLOCK¿ PORT, 5
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• 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: 21699474
• Report Number: 9617594-2025-00559
• Device Sequence Number: 18291013
• Product Code: ONB
• UDI-Device Identifier: 00887709123878
• UDI-Public: 00887709123878
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131549
• 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): 05/07/2025

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: CL4180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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