MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH2000SC-10
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unknown date involving a spiros®, closed male luer w/red cap, 10 units where it was reported that the customer had a handful of spiros disconnections from the end of syringes/cadd tubing.This issue was not every day but occasionally.There was unknown patient involvement, unknown patient harm and unknown delay in therapy.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
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.No lot received for a device history review (dhr) review.D9 - device available for evaluation: no.

• Brand Name: SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS
• 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: 22297855
• Report Number: 9617594-2025-01303
• Device Sequence Number: 8628548
• Product Code: FPA
• UDI-Device Identifier: 00840619042769
• UDI-Public: 00840619042769
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: CH2000SC-10
• Device Lot Number: UNKNOWN
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CADD TUBING, MFR UNK.; SYRINGE, MFR UNK.
• Patient Sex: Unknown