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 Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Additional used device has been received for the investigation and a reported incident involving a spinning spiros closed male luer, red cap.It was reported that spiros did not securely attach to tubing, fell off.Spiros became detached during iv push medication administration via syringe through a peripheral and central line, which resulted in chemo spill, lost drug, and drug contamination.Although there was patient involvement, no patient harm occurred.
Additional Manufacturer Narrative
Seven used samples were received for evaluation.Each sample was observed to have an activated spin collar.A dhr lot # review could not be conducted because no lot numbers were identified.The reported complaint of a leak and disconnection could be confirmed.The returned samples were observed to be disconnected with the spin collar activated.The probable cause is from an automation error in (b)(6).

• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50843453
• Report Number: 9617594-2026-01315
• Device Sequence Number: 13327854
• Product Code: ONB
• UDI-Device Identifier: 00840619026615
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 09/21/2026

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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/21/2026
• 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
• Patient Sex: Unknown