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

Catalog Number	CH-12
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An email was received regarding a chemoclave bag spike with additive port dry spike stating that there were small particles noted after using specific ch-72 vial spikes to compounding busulfan and infusing it through the ch-12 adapter into the final bag.No patient involvement and harm.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
One used list #ch-12, chemoclave® bag spike with additive port dry spike connected to an unknown, busulfan (ndc 71288011610) 250ml bag were returned for evaluation.As received, the dry spike adaptor was not punctured and no debris, contaminations or anomalies floating inside the busulfan bag was noted either.The fluid path of the sample was filtered in attempt to identify any particles or fibers; no anomalies were noted.The customer's complaint of particulate matter cannot be confirmed or replicated based on evaluation of the physical sample returned by customer.A device history record review could not be conducted because no lot number was identified.D9 - date returned to mfr: 24feb2026.Corrected information can be found in e3 - initial reporter occupation and g2 - report source.

• Brand Name: CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT DRY 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: 24305578
• Report Number: 9617594-2026-00113
• Device Sequence Number: 9678524
• Product Code: ONB
• UDI-Device Identifier: 00840619023713
• UDI-Public: 00840619023713
• Combination Product (Y/N): N
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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-12
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/20/2026
• 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: BUSULFAN (NDC 71288011610), UNK MFR.; CHEMOCLAVE VENTED VIAL SPIKE (CH-72).
• Patient Sex: Unknown