MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH2000S-PC
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: two (2) photos were shared by customer, where 5 syringes with medicine are connected with a spiros.However, no visible damage or anomalies are observed shown on the photos.Complaint of unable to push the methotrexate through the syringe as the plunger was stuck, cannot be confirmed based on the photo shared by customer.Without the return of the affected item for investigation a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.The device history record lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.
Event or Problem Description
A complaint was received regarding a spinning spiros closed male luer, purple cap that experienced no flow upon medication draw.This is report 1 of 2.The methotrexate syringe reportedly could not be pushed or administered by the patient due to a stuck plunger on the device.This occurred during preparation for administration.The customer advised that the patient was going to try again later that night.This patient has been using the methotrexate syringe from baxter for 8 years and this is the first issue they have encountered.The patient mentioned that they had to fiddle around with the needle a little bit to get it to sit on the syringe.It was confirmed that product packaging came in good condition as per usual.There was no medical intervention was required and no injury was reported to be associated with the event.There were 6 units associated with this reported complaint.

• Brand Name: SPINNING SPIROS® CLOSED MALE LUER, PURPLE CAP
• 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: 21660671
• Report Number: 9617594-2025-00522
• Device Sequence Number: 15688534
• Product Code: FPA
• UDI-Device Identifier: 00840619027568
• UDI-Public: (01)00840619027568(17)290401(10)13963051
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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-PC
• Device Lot Number: 13963051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/11/2024
• 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