MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. Spinning Spiros® Closed Male Luer, Red Cap; Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System

Catalog Number	CH2000S-C
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A reported incident involving a spinning spiros closed male luer, red cap.It was reported that when attaching the spiros to the primary tubing, the spiros acted as if it clicked on.When double checking it was secure, the registered nurse was able to pull it off the tubing.The event occurred prior to patient use after priming tubing.There was no patient involvement or harm.
Additional Manufacturer Narrative
The device has been received for evaluation; however, investigation is not yet complete.

• Brand Name: Spinning Spiros® Closed Male Luer, Red Cap
• 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: 50791732
• Report Number: 9617594-2026-01281
• Device Sequence Number: 9570587
• Product Code: ONB
• UDI-Device Identifier: 00840619026615
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care 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: CH2000S-C
• Device Lot Number: 14931076
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2026
• 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