MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. Oncology Kit w/12" Ext Set, Spiros® w/Red Cap, Clamp, Graduated Adapter; ChemoCl; Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System

Catalog Number	CH3943
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a oncology kit, 12 in ext, 2 spiros, graduated adapter, 2 chemoclave vial spike 1 13mm 1 20mm.It was reported that bcg tubing being defective and she changed the tubing and it worked fine also add it occurred during dos.When administering the bcg, the blue connector that they are supposed to connect to the foley catheter was stuck inward, which would not allow medicine to flow to gravity.There was a patient involvement and no reported harm.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.The event history log was unable to be reviewed as the product was not returned.

• Brand Name: Oncology Kit w/12" Ext Set, Spiros® w/Red Cap, Clamp, Graduated Adapter; ChemoCl
• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50789922
• Report Number: 9617594-2026-01278
• Device Sequence Number: 21186054
• Product Code: ONB
• UDI-Device Identifier: 00887709082632
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: CH3943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/16/2026
• 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