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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: additional phone number reported: (b)(6).The investigation is pending completion.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding 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 that experienced leakage.This is report 2 of 3.The reporter stated that they encountered leaking from their cadd oncology kit.The event date occurred on 06-jan, 08-jan and 10-jan-2025.Status was while in use in patient.The samples are available for evaluation.Thus, there was patient involvement, unknown human harm and unknown delay in therapy reported.
Additional Manufacturer Narrative
The reported complaint of a leak 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 was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in: b1 - adverse event/product problem.B2 - death date null.D7a - single use device.D10 - concomitant products.H6 - health effect - impact code.Updated information can be found in: b5 - describe event or problem.D9 - device available for evaluation.D9 - date returned to mfg null.
Event or Problem Description
The sample is no longer available for investigation.
Additional Manufacturer Narrative
Additional information in section b5.
Event or Problem Description
An email from the customer was received on 09-apr-2026 confirming that there was no patient harm.

• 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: 21657947
• Report Number: 9617594-2025-00520
• Device Sequence Number: 15561167
• Product Code: ONB
• UDI-Device Identifier: 00887709083271
• UDI-Public: (01)00887709083271(17)290901(10)14134777
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 04/09/2026
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 07/14/2025; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/07/2024
• 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: CADD ONCOLOGY KIT, MFR ICU MEDICAL.; CADD ONCOLOGY KIT, MFR UNKNOWN.; UNKNOWN INFUSATE, MFR UNKNOWN.; UNKNOWN INFUSATE, MFR UNKNOWN.
• Patient Sex: Unknown