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 Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
Event or Problem Description
It was reported via medwatch report (b)(4) that the patient was admitted to bone marrow transplant unit on (retracted date).New iv lines were made with a quadfuse that had bonded chemolock on one arm.The nurse found the luer lock had disconnected from the quad fuse.The luer lock remained on the patient's microclave cap closest to the patient while the quad fuse was laying on the bed.There was blood loss.The nurse was unsure of the amount of the blood loss.The original intended procedure was iv chemotherapy delivery.The problem of the user was the device failed.Therapies being used on the patient at the time of event that may have caused or contributed to the event was chemotherapy.There was no patient harm reported.

• 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: 21759071
• Report Number: 9617594-2025-00627
• Device Sequence Number: 8611082
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 04/02/2025
• 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
• Patient Age: 18 MO
• Patient Sex: Female
• Patient Weight: 13 KG