MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5.5" (14 CM) APPX 0.55 ML, SMALLBORE TRIFUSE EXT SET W/3 CHEMOCLAVE®, SPIROS® W/; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3700
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is reported to not be available for return, however, a lot review should be completed.
Event or Problem Description
Event occurred on an unspecified date involving a 5.5" (14 cm) appx 0.55 ml, smallbore trifuse ext set w/3 chemoclave¿, spiros¿ w/red cap, 3 clamps where the reporter stated that during infusion, when they clamp the pinch clamps, they aren't clamping down all the way and fluid is able to escape into the other lumens.There was patient involvement and no adverse event as a result of this event.
Additional Manufacturer Narrative
Investigation summary- the complaint could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 5.5" (14 CM) APPX 0.55 ML, SMALLBORE TRIFUSE EXT SET W/3 CHEMOCLAVE®, SPIROS® W/
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22284552
• Report Number: 9617594-2025-01274
• Device Sequence Number: 15533585
• Product Code: ONB
• UDI-Device Identifier: 00887709089181
• UDI-Public: (01)00887709089181(17)290701(10)14090224
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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: CH3700
• Device Lot Number: 14090224
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED DRUG.
• Patient Sex: Unknown