MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. Oncology Kit w/ChemoLock¿ w/ChemoClave®; Spinning Spiros® w/Red Cap; Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Model Number	UNKNOWN
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H4 - device mfr date, d4 - serial, d4 - catalog number was unknown the device has been received for evaluation; however, investigation is not yet complete.
Event or Problem Description
The event involved a oncology kit w/chemolock w/chemoclave; spinning spiros w/red cap with unknown ln and sn: it was reported that the registered nurse reports a onetime event of syringe leaking when using chemolock spinning spiros on syringe and it seems that the liquid was leaking somewhere around spiros piece.There was no reported patient involvement and harm.

• Brand Name: Oncology Kit w/ChemoLock¿ w/ChemoClave®; Spinning Spiros® w/Red Cap
• Common Device Name: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 25443785
• Report Number: 9617594-2026-00556
• Device Sequence Number: 18507889
• Product Code: ONB
• UDI-Device Identifier: 00887709079182
• UDI-Public: (01)00887709079182
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• 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): 08/17/2026

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 Model Number: UNKNOWN
• Device Catalogue Number: CL3941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Supplement Date Received by Manufacturer: 08/08/2026
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown