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	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two used devices were returned for evaluation on 2/19/2026 along with various mating devices.A photo was returned showing the packaging information of the ch2000s-c spinning spiros and the bd alaris set.The spiros and mating devices were leak tested.There was no leakage.The reported complaint of leakage was unable to be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 feb 2025 has been used as a placeholder.The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
A complaint was received with regards to a spinning spiros closed male luer, red cap in which it was reported that there was a defective spinning spiros that led to a chemo spill.The spinning spiros was being used with the bd tubing.There was patient involvement and no reported patient harm.Additionally, the customer updated, that it was unknown if the patient had any mtx get on his skin.Nursing cleaned patient up per policy, removed gown, changed linen, and there was chemo on the fitted sheet beneath the patient.There was a delay as a new partial dose had to be made up.

• 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: 24373168
• Report Number: 9617594-2026-00152
• Device Sequence Number: 5572574
• Product Code: ONB
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)300901(10)14611639
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 04/14/2026

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: 14611639
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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: METHOTREXATE 1650MG, MFR UNKNOWN; UNSPECIFIED TUBING, BD MEDICAL
• Patient Sex: Unknown