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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
An email was received with regards to a spinning spiros closed male luer, red cap generated a leak during patient use.It was reported that there may have been a defect in the spiros transfer device, causing it to leak.Additionally, it was stated that they may not have connected the needle to the spiros connector completely.The event occurred during patient use for 2 minutes.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
Received one (1) new.List #ch2000s-c, spinning spiros® closed male luer, red cap; lot #14149695.No visual damages or anomalies were observed.The reported complaint of a leak could not be confirmed.The returned sample was tested, and a leak was unable to be replicated.Without the return of the used sample a probable cause cannot be determined.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 24324152
• Report Number: 9617594-2026-00123
• Device Sequence Number: 9541516
• Product Code: ONB
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)290901(10)14149695
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 14149695
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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
• Patient Sex: Unknown