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 Code	Chemical Exposure (2570)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved an 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 where it was reported there were 4 occasions of leaking coming from the bonded chemolock port on the drug additive port of this set.5fu was needed to be discarded and remade causing delay in patient care and additional staff time and resources in making new medications.It was stated that the events occurred during compounding and although it did come in contact with the technician's hands; the technician was double gloved, and no unprotected exposure reported.However, there was an event that occurred on a patient at home.The patient was exposed to fluorouracil on their skin and clothes.The patient returned to the healthcare facility and was de-accessed.The chemo spill was cleaned up per facility protocol.The event occurred while mixing and questionable leak at home with a patient.No harm reported.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Additional Manufacturer Narrative
Investigation summary: received one (1) used list# (b)(4), 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; lot# 14134777.No visual damages or anomalies were observed.The reported complaint of a leak could be confirmed.The returned sample leaked during testing.The probable cause of the leak is from an incomplete insertion during manufacturing.The lot history was reviewed; no nonconformities were identified that may have contributed 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: 22359155
• Report Number: 9617594-2025-01389
• Device Sequence Number: 7998033
• Product Code: ONB
• UDI-Device Identifier: 00887709083271
• UDI-Public: (01)00887709083271(17)290901(10)14134777
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 08/19/2025

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: 14134777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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, UNK MFR.
• Patient Sex: Unknown