MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 61" (155 CM) APPX 0.41 ML, SMALLBORE EXT SET W/CHEMOCLAVE®, SPIROS® W/PURPLE CAP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3672
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available and we are expecting a review of the dhr.Initial reporter phone number ext (b)(6).
Event or Problem Description
The complaint involved a 61" (155 cm) appx 0.41 ml, smallbore ext set w/chemoclave®, spiros® w/purple cap, clamp.It was reported that the set leaked during chemotherapy infusion.There was no blood loss and no unprotected chemo exposure.There was no adverse operator consequences and no med/surg intervention required.The device was changed out/replaced with no further problems encountered.There was no identity of involved/mating devices.There was unknown patient involvement, no patient harm and no delay in therapy.
Additional Manufacturer Narrative
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.Lot history review was conducted no nonconformities were found that would have led to the reported complaint.

• Brand Name: 61" (155 CM) APPX 0.41 ML, SMALLBORE EXT SET W/CHEMOCLAVE®, SPIROS® W/PURPLE CAP
• 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: 22293787
• Report Number: 9617594-2025-01291
• Device Sequence Number: 21055936
• Product Code: ONB
• UDI-Device Identifier: 00887709087477
• UDI-Public: (01)00887709087477(17)290701(10)14070594
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: CH3672
• Device Lot Number: 14070594
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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 MATING DEVICE, MFR UNK; UNSPECIFIED MEDICATION, MFR UNK
• Patient Sex: Unknown