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	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event involving a spinning spiros closed male luer, red cap reported that registered nurse (rn) went into patient's room to check on patient and patient noticed one of his tubing's (the hazardous spiros) came off and blood was backing up into trifuse.Chemotherapy was not infusing through that line at the time.The rn stopped the infusion running through the syringe line and observed that the spiros cap on the primary tubing had detached, although the c-cap remained secure.The provider at the bedside was notified, and the rn cleaned and replaced the tubing.Prior to initiating the hazardous tubing line, the rn had verified that both the hazardous spiros cap and the c-cap were secure and functioning properly.The event resulted in the need for increased patient monitoring.There was patient involvement and no harm/adverse event reported.
Additional Manufacturer Narrative
The device has been requested for evaluation, however, it has not yet been received.D4: only di provided as lot number is unknown.
Additional Manufacturer Narrative
Additional information was provided via a1 - additional information provided regarding patient information.E1 - additional contact provided on medwatch: (b)(6).E4 - fda notified - yes.H10 - medwatch number provided.
Additional Manufacturer Narrative
D9 - date returned to mfr: 2/20/2026.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.The spiros was functional activated with no anomalies, the male and female luer passed the iso design expectations as well.Complaint of tubing came off can be confirmed.However, the probable cause was because spiros was never activated in the first place, 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.A device history review (dhr) could not be conducted because no lot number(s) was/were identified.

• 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: 24427496
• Report Number: 9617594-2026-00174
• Device Sequence Number: 9730801
• Product Code: ONB
• UDI-Device Identifier: 00840619026615
• UDI-Public: 00840619026615
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2026

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: UNKNOWN
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 04/17/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/10/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 DRUG, UNK MFR.
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White