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

Catalog Number	CH2000S
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an accidental disconnection of a spinning spiros®, closed male luer from a primary plum set (ref 14007) during patient use.This event took place two weeks prior to the complaint was received and the problem was detected during the early morning, after the patient went to the bathroom and returned to their bed.At that moment, the patient called for nursing assistance because they felt wet.The nurse responded immediately and noticed that the disconnection.Upon questioning the patient, they reported not feeling any entanglement or traction from the device.The spiros connection was directly attached to a bifurcated extension # 3312 from icu medical, through which saline solution was being infused with a midline.There was no decompensation or harm to the patient, and no treatment or blood transfusion was required.It was also reported that the product was contaminated with blood and chemotherapy drugs.It was confirmed that there was no contact with chemotherapy since the line the spiros had disconnected from was a primary infusion line that was connected directly to the patient's vascular access.
Additional Manufacturer Narrative
The device is not available for investigation.However, a photograph was provided by the customer and evaluation of the photo is pending.
Additional Manufacturer Narrative
One photo was returned for investigation.The reported complaint of a leak could be confirmed from the photo provided.However, without the return of the sample a comprehensive review cannot be performed and a probable cause cannot be determined.A device history review could not be completed due to the unknown lot number.

• Brand Name: SPINNING SPIROS®, CLOSED MALE LUER
• 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: 23760604
• Report Number: 9617594-2025-02277
• Device Sequence Number: 18664852
• Product Code: ONB
• UDI-Device Identifier: 00840619033903
• UDI-Public: (01)00840619033903
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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
• Device Lot Number: UNKNOWN
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/12/2026
• 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: BIFURCATED EXTENSION 3312, MFR ICU MEDICAL.; PRIMARY PLUM SET (REF 14007), LOT UNK, MFR ICU MED.; SALINE SOLUTION, MFR UNK.; UNSPECIFIED CHEMOTHERAPY DRUGS, MFR UNK.; UNSPECIFIED VASCULAR ACCESS DEVICE, MFR UNK.
• Patient Sex: Unknown