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	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a spinning spiros closed male luer, red cap.It was reported that spiros sounded as if it was clicked onto primary tubing, but when staff double checked, they were able to completely pull the spiros off the tubing.The event occurred prior to patient use, connecting to primary tubing.There was no delay in therapy.Sample was retained with no contaminants.The outcome of the event was new supplies obtained, treatments provided there were no patient involvement and harm.
Additional Manufacturer Narrative
Device was returned for investigation.It was reported that as received, the spinning mechanics was already activated and some damage inside the spinning mechanic was observed.No mating device was returned for evaluation.The spiro was torque tested and met the product specifications.Complaint of disconnection / loose connection was able to be confirmed.The probable cause was an error during assembly process.Device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.(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: 50869584
• Report Number: 9617594-2026-01323
• Device Sequence Number: 9425465
• Product Code: ONB
• UDI-Device Identifier: 00840619026615
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 14931076
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2026
• 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