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	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A reported incident involving a spinning spiros closed male luer, red cap, spiros connector failed during a blincyto (blinatumomab) infusion.The spiros was observed to have become disconnected from the tubing connection site.The patient's caregiver reported that the connector "fell off." attempts by the nurse to reconnect the spiros were unsuccessful, as the connector continued to rotate and would not attach to the tubing luer lock.The event occurred during therapy.There were no reported patient involvement and no injury or adverse event reported.
Additional Manufacturer Narrative
Device has not been returned to manufacturer.A supplemental mdr will be filed when additional information becomes available.

• 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 ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50011434
• Report Number: 9617594-2026-00925
• Device Sequence Number: 8385156
• Product Code: ONB
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)301101(10)14781260
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2026

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: 14781260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/24/2025
• 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: Blincyto
• Patient Sex: Male
• Patient Weight: 78 LB