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	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reporter that the device has been discarded.A lot review will be completed.
Event or Problem Description
The event occurred involving 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.The customer reported that the cassette tubing leaked (from what appeared to be from the blue port used to fill the cassettes ) while the pump was attached to the patient midway through their 46hrs therapy.The customer stated that it there was exposure to the unspecified chemotherapy medication; no intervention was reported.There was patient involvement, a slight delay in therapy, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
A photo was returned showing the cl3960.Fluid residuals were observed outside of the fluid path.The reported complaint can be confirmed.The probable cause of the leakage is due to an incomplete insertion during the manual assembly of manufacturing.The dhr was reviewed and no nonconformities were found that would have led to the reported complaint.Similar complaints from this lot had samples received with incomplete insertions found on the chemolock to female luer bond.Corrected information can be found in h6 health effect - impact code, d10 concomitant products, e1 - initial reporter zip code, e3 - initial reporter occupation and health effect - clinical code.

• 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: 23039574
• Report Number: 9617594-2025-01849
• Device Sequence Number: 15920530
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• 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: UNSPECIFIED CASSETTE TUBING DEVICE, MFR UNK.; UNSPECIFIED CHEMO.; UNSPECIFIED CHEMOTHERAPY, MFR UNK.; UNSPECIFIED INFUSION PUMP, MFR UNK.
• Patient Sex: Unknown