MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS¿, CLOSED MALE LUER W/RED CAP, 10 UNITS; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH2000SC-10
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.A lot number has been provided.A device history lot number review is pending.
Event or Problem Description
The event occurred on an unspecified date in may 2025 and involved a spiros¿, closed male luer w/red cap, 10 units where it was reported that spiros leaked outside of internal chamber of device.The event occurred during infusion.There was patient involvement, no adverse event but there was delay in therapy.
Event or Problem Description
A medsun medwatch uf/importer report #(b)(4) was received on 25-aug-2025 stated that the spiros in use for intrathecal methotrexate was faulty, and drug was leaking outside of the chamber of the closed system.Incident did not reach the patient.The original intended procedure was for chemotherapy treatment.
Additional Manufacturer Narrative
Received one (1) used unit ch2000sc-10 spiros connected to one (1) used list# unknown 10 ml syringe for inspection.Yellow fluid appeared to be outside of the fluid path as received.Fluid was infused and withdrawn with the syringe.No restrictions in flow and no leakage.The set was leak tested per product specifications.There was no leakage.The reported complaint can be confirmed due to the evidence of internal leakage as received.The probable cause is unknown.The complaint was unable to be replicated or confirmed.The device history lot number was reviewed, and no nonconformities were found that would have led to the reported complaint.Updated information in d9.Additional information in section b, d10, e, and g.

• Brand Name: SPIROS¿, CLOSED MALE LUER W/RED CAP, 10 UNITS
• 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: 22367370
• Report Number: 9617594-2025-01399
• Device Sequence Number: 7918561
• Product Code: ONB
• UDI-Device Identifier: 00840619042769
• UDI-Public: (01)00840619042769(17)290501(10)13999800
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: CH2000SC-10
• Device Lot Number: 13999800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/15/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: METHOTREXATE, UNK MFR
• Patient Sex: Unknown