MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK¿ PORT, CL; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3960
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint involved a oncology kit w/60" (152 cm) appx 2.2 ml, smallbore ext set w/chemolock¿ port, clamp, anti-siphon valve, spiros®; chemolock¿; syringe transfer set w/microclave®, chemolock¿ port.It was reported that there was leaking observed where it is connected to the chemolock port.Two incidents happened when the patients were home with their pumps.This report captures the second of two events.There was unintended exposure to chemotherapy.The medication was leaking from the tubing, causing for chemotherapy to be outside the closed system.Two incidents happened with one patient - the tubing was leaking, pump replaced, then the new tubing leaked.The last incident happened for another patient where the tubing was leaking at home.There was patient involvement and unknown adverse event.
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Additional Manufacturer Narrative
Investigation summary: photos were provided showing the packaging information and a pen pointing to the area of leakage on the cl3960.No leakage observed in the photo.Received one (1) used cl3960 oncology kit connected to one (1) used list# unknown cadd set.No defects or anomalies noted.The set was leak tested per product specifications.There was a slow leak from the connection of the female luer y-site to the male luer of the chemolock.Examination of the connection showed an incomplete insertion.The reported complaint of leakage can be confirmed.The probable cause is due to an incomplete insertion during manual assembly in ensenada.The device history was reviewed and no relevant nonconformities were found that would have led to the reported complaint.

• Brand Name: ONCOLOGY KIT W/60" (152 CM) APPX 2.2 ML, SMALLBORE EXT SET W/CHEMOLOCK¿ PORT, CL
• 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: 22302079
• Report Number: 9617594-2025-01308
• Device Sequence Number: 8562512
• Product Code: ONB
• UDI-Device Identifier: 00887709083271
• UDI-Public: (01)00887709083271(17)291001(10)14196319
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/12/2025

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: CL3960
• Device Lot Number: 14196319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLUOROURACIL.; UNSPECIFIED PUMP, MFR UNK.; UNSPECIFIED TUBING, MFR UNK.
• Patient Sex: Unknown