MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® VENTED BAG SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH-14
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An event occurred regarding a chemoclave® vented bag spike, alleging that there was a leakage of an unknown chemotherapy drug at the junction between the spiros and the lower tubing.There was patient involvement, no patient harm, and there was no delay in critical therapy.
Additional Manufacturer Narrative
Received two (2) used ch-14 connected to various mating devices.One (1) of the ch-14 had a stick down.No defects or anomalies noted on the other ch-14.Each ch-14 was leak tested with the mating devices per product specifications.There was no flow through the stuck down ch-14.There were no restrictions in flow or leakage on the other ch-14.The ch-14 was disassembled and found to be bent and broken.The reported complaint of leakage can be confirmed due to the stuck down microclave.The probable cause is unknown.The device history review (dhr) could not be reviewed due to the unknown lot number.
Additional Manufacturer Narrative
Received two (2) used ch-14 connected to various mating devices.One (1) of the ch-14 had a stick down.No defects or anomalies noted on the other ch-14.Each ch-14 was leak tested with the mating devices per product specifications.There was no flow through the stuck down ch-14.There were no restrictions in flow or leakage on the other ch-14.The ch-14 was disassembled and found to be bent and broken.The reported complaint of leakage can be confirmed due to the stuck down microclave.The probable cause is unknown.The device history review (dhr) could not be reviewed due to the unknown lot number.

• Brand Name: CHEMOCLAVE® VENTED BAG SPIKE
• 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: 23500818
• Report Number: 9617594-2025-02137
• Device Sequence Number: 8992593
• Product Code: ONB
• UDI-Device Identifier: 00840619023751
• UDI-Public: 00840619023751
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: CH-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 03/05/2026
• 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: UNSPECIFIED CHEMO, UNK MFR.
• Patient Sex: Unknown