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	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.Additional reporter details: (b)(6).
Event or Problem Description
An event involved a chemoclave vented bag spike reported that it always had air in line during infusion.An unknown chemo drug was involved in the event.There was no bleed back reported.The product is not a biohazard, and the device was not reprocessed/resterilized.There was patient involvement but no patient harm.There was no delay in critical therapy.
Additional Manufacturer Narrative
Two used devices were received for evaluation on (b)(6) 2026, connected to an unknown, bag spike adaptor w/ spiros and an unknown, primary plum set and one of them additionally connected to a, 0.9% sodium chloride 500ml bag were returned for evaluation.As returned, there was no physical damage or anomalies.The samples were primed and no flow restriction or occlusion were noted.The claves were dissembled and a crushed spike in just one clave was noted, no additional damage or anomalies were noted.Complaint can be confirmed.The probable cause is unknown.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Additional information b5 section.
Event or Problem Description
Additional information was provided stating that the device generated an alarm.

• 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: 24186454
• Report Number: 9617594-2026-00037
• Device Sequence Number: 15447655
• Product Code: ONB
• UDI-Device Identifier: 00840619023751
• UDI-Public: (01)00840619023751(17)300601(10)14442423
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 14442423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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: BAG SPIKE ADAPTER W/SPIROS¿, ICU MEDICAL.; UNKNOWN CHEMO DRUG, UNK MFR.
• Patient Sex: Unknown