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

Catalog Number	CH2000-C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
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.
Event or Problem Description
It was reported that, on an unspecified date, a spiros closed male luer, red cap experienced a separation during patient use.The report states that spiros disconnected from chemotherapy.There was no patient harm reported.The initial reporter indicated that the event occurred four times; however, no additional information was given pertaining to the additional instances.A search of the complaint database showed no prior report of these events.
Additional Manufacturer Narrative
D9 - device available for evaluation: no.The complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) was reviewed, and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 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: 22605356
• Report Number: 9617594-2025-01530
• Device Sequence Number: 9604081
• Product Code: ONB
• UDI-Device Identifier: 00840619023799
• UDI-Public: (01)00840619023799(17)300301(10)14331348
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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: CH2000-C
• Device Lot Number: 14331348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2025
• 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: UNSPECIFIED CHEMO, UNK MFR
• Patient Sex: Unknown