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	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received with regards to 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 that experienced breakage and leakage during use.The reporter stated that "all the breaks happened where the male luer lock inserts into the patient¿s microclave cap.They think it may be a bonding issue.This resulted in blood loss and ivf loss for the patients, chemo spills, and can potentially cause great harm for the patients." "patients did not suffer harm as these were found quickly, but the patient¿s did lose blood and chemo was also spilled".
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2024 has been used as a placeholder.Customer gave a time range rather than a date in 2024.D4 and h4 the lot#, expiration date, and manufacture date are unknown.The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Additional Manufacturer Narrative
The reported complaint of a separation 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.The lot history review could not be conducted because no lot number was provided.
Additional Manufacturer Narrative
Correction to h6 code for type of investigation - should just be b17 and not b14.Lot number was not provided, therefore, lot history review could not be performed.

• 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: 21339788
• Report Number: 9617594-2025-00245
• Device Sequence Number: 19795669
• 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,Followup
• Report Date (Section B): 03/25/2025

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: 01/10/2025
• Supplement Date Received by Manufacturer: 02/27/2025; 02/27/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/25/2025; 03/25/2025
• 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