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

Catalog Number	CH2000-C
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one (1) used list# ch2000-c, spiros® closed male luer, red cap connected to an unknown used, infusion set and one additional used list# ch2000-c, spiros® closed male luer, red cap were returned for evaluation.As received one of the spiros came wrapped with a piece of tape.No additional damage or anomalies were observed.The returned set was tested as procedure and a steam of water coming from a crack on the spiro's female luer was observed, this was not on the part line, the male luer was iso measured finding within specification.Complaints of leaks can be confirmed.The probable cause of the crack is unknown.
Event or Problem Description
A complaint was received regarding a spiros® closed male luer, red cap that experienced leakage.It was reported that the methotrexate leaked from the spiros - trifuse connection point.Spiros was fully attached and could spin a full 360.There was unknown patient involvement.

• Brand Name: SPIROS® CLOSED MALE LUER, RED 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: 22120421
• Report Number: 9617594-2025-01135
• Device Sequence Number: 7157066
• Product Code: FPA
• UDI-Device Identifier: 00840619023799
• UDI-Public: 00840619023799
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2025

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: CH2000-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/31/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: METHOTREXATE, MFR UNKNOWN.
• Patient Sex: Unknown