MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS®, CLOSED MALE LUER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH2000S
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Event or Problem Description
A spinning spiros®, closed male luer reportedly disconnected from the tubing at point of connection during a patient's infusion of medication (cyclophosphamide, tepotecan, and vincristine).There was no harm and there was an unspecified delay in therapy.
Additional Manufacturer Narrative
Device received on 10/9/2025.Investigation summary: received the following: one (1) used.List #ch3661, 14" (36 cm) appx 4.3 ml, bifuse add-on set w/bag spike, spiros® w/red cap, 2 clamps (blue, red), vented cap, drop-in spiros® w/red cap; lot #14406717.One (1) used.List #unknown, infusion set; lot #unknown.One (1) used.List #ch2000s, spinning spiros¿, closed male luer; lot #13915376.One (1) used.List #ch3661, 14" (36 cm) appx 4.3 ml, bifuse add-on set w/bag spike, spiros® w/red cap, 2 clamps (blue, red), vented cap, drop-in spiros® w/red cap; lot #14406717.One (1) used.List #unknown, infusion set; lot #unknown.One (1) used.List #ch2000s, spinning spiros¿, closed male luer; lot #13915376.Both systems were observed to have the spiros disconnected and the spin collar activated.The reported complaint of the spiros disconnecting could be confirmed.The returned used sample was observed to have an activated spin collar and disconnected from the mating device no damage was observed on the shear tabs.However, the sample was tested and met product specifications.The probable cause of the disconnection is unknown.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: SPINNING SPIROS®, CLOSED MALE LUER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 23375618
• Report Number: 9617594-2025-02036
• Device Sequence Number: 18360314
• Product Code: FPA
• UDI-Device Identifier: 00840619033903
• UDI-Public: (01)00840619033903(17)290201(10)13915376
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: CH2000S
• Device Lot Number: 13915376
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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: CYCLOPHOSPHAMIDE, MFR UNK.; TEPOTECAN, MFR UNK.; VINCRISTINE, MFR UNK.
• Patient Sex: Unknown