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	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: the date of event is unknown in december 2025, and 01 dec 2025 has been used as a placeholder.The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received with an attached user facility mandatory medwatch report number: (b)(4) with regards to a spinning spiros® closed male luer, red cap in which it was reported that they attached the spiros easily to the b channel but when they opened the roller clamp, chemo began to spew out of the spiros on the side and liquid got onto the tubing, chip, and pump.They quickly held the chemo bag over the connection to block the spray and closed the clamp, stopping the flow.Chemo residue was on the pump and no liquid chemo sprayed onto the patient or on the medical professional.It causes one hour delay for patient therapy.A whole new bag and set up was provided.The patient involved was not harmed.
Additional Manufacturer Narrative
Updated information in d9 - device available for evaluation, concomitant product.Correction in b2- outcomes attributed to ae null, h6 (health effect - impact code).The device was discarded and is not available for investigation.Without the return of the device a probable root cause is unable to be determined.The device history record (dhr) was reviewed, and no nonconformities were found that would have led 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: 24297790
• Report Number: 9617594-2026-00101
• Device Sequence Number: 10166363
• Product Code: ONB
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)300701(10)14480063
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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: 14480063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2025
• 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 BAG, UNK MFR.; UNSPECIFIED IV SET, MFR UNK.; UNSPECIFIED PUMP, MFR UNKNOWN.
• Patient Age: 20 YR
• Patient Sex: Female