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	Chemical Exposure (2570)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.(b)(6).
Event or Problem Description
The event involved spinning spiros, and it was reported that a spiros detach from a primary line, causing medication to leak.The drug leaked onto the patient¿s clothes, mainly on her abdomen and leg. the patient removed her clothes and washed the area 3 times with soap and water, then put on hospital scrubs.Patient's skin was intact and no irritation when she left our infusion center.There was a delay of about an hour since the remaining drug had to be stopped until the spill is cleaned and contact the provider.There was patient involvement, and no patient harm was reported.
Additional Manufacturer Narrative
Investigation summary: one (1) used.List #ch2000s-c, spinning spiros® closed male luer, red cap was returned for evaluation.As received, the spinning mechanism was not activated.No additional damage or anomalies were confirmed.No damage on the spiro's splines and good shear tab activation was observed.The male and female luer passed the iso design expectations as well.Complaint of disconnection / loose connection can be confirmed.The probable cause spiros was never activated correctly, according dfu instructions.- grasp spiros and attach to standard male luer of administration device.Attach in a straight manner.Twist devices together until a click is heard and the spiros begins to rotate freely.Spiros is now permanently attached to luer.The lot history was reviewed; 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: 24493849
• Report Number: 9617594-2026-00213
• Device Sequence Number: 12006987
• Product Code: ONB
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)301001(10)14638114
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• 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: 14638114
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2025
• 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: CYTOXAN, UNK MFR; PRIMARY LINE, UNK MFR; TAXOTERE, UNK MFR
• Patient Sex: Unknown