MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152CM) 0.41 ML, SMALLBORE EXT SET W/CHEMOCLAVE®, SPIROS® W/RED CAP, CLAMP; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3147
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending.The device history report will be reviewed.
Event or Problem Description
The event occurred on an unspecified day in august 2025 in the hospital involving a 60" (152cm) 0.41 ml, smallbore ext set w/chemoclave®, spiros® w/red cap, clamp where it was reported that the tubing was leaking chemo somewhere near the spiros.There was patient involvement but no report of harm.
Additional Manufacturer Narrative
The complaint record was voided due to duplicate of existing complaint record.This mfr mdr report# 9617594-2025-01977 is a duplicate of mfr mdr report# 9617594-2025-01910.Please consider this report, 9617594-2025-01977, void.

• Brand Name: 60" (152CM) 0.41 ML, SMALLBORE EXT SET W/CHEMOCLAVE®, SPIROS® W/RED CAP, CLAMP
• 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: 23285466
• Report Number: 9617594-2025-01977
• Device Sequence Number: 15692405
• Product Code: ONB
• UDI-Device Identifier: 00840619033941
• UDI-Public: (01)00840619033941(17)300601(10)14459371
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/08/2026

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: CH3147
• Device Lot Number: 14459371
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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: SPIROS, MFR UNK.; UNSPECIFIED CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown