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	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 oct 2025 has been used as a placeholder.Investigation summary.The reported complaint of disconnection could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed, and a probable cause cannot be determined.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
Event occurred regarding a product description of the spiros.It was reporter that three patients were sent home with a spiros at the end of their blinatumomab tubing, and there have been disconnections.There was no report of patient harm.

• 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: 23426331
• Report Number: 9617594-2025-02098
• Device Sequence Number: 9854271
• Product Code: FPA
• UDI-Device Identifier: 00840619033903
• UDI-Public: (01)00840619033903(17)291101(10)14196247
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/30/2025

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: 14196247
• 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: 10/06/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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
• Patient Sex: Unknown