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	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.The investigation is pending completion.The sample should be available to be sent, but has not yet been received.Upon completion of the investigation a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received with regards to a spinning spiros¿, closed male luer that experienced breakage and leakage.The reporter stated that the spinning spiros closed male luer was found to have a torn/cut/broken on the blue elastic part.They have seen 7 occurrences of leaking spiros so far.The event date was unknown.Sample photo showing the defective product was provided.
Additional Manufacturer Narrative
Two photos were returned showing the spiros.One photo showed the spiros with the blue strap intact.The other photo showed the blue strap broken.The reported complaint of the broken strap and subsequent leakage can be confirmed.The probable cause is unknown.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Lot history review was conducted, and no nonconformities were found that would have led to the reported complaint.

• 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: 21611786
• Report Number: 9617594-2025-00489
• Device Sequence Number: 18067496
• Product Code: ONB
• UDI-Device Identifier: 00840619033903
• UDI-Public: (01)00840619033903(17)270301(10)5870898
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

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: 5870898
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2022
• 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
• Patient Sex: Unknown