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

Catalog Number	CH-13
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received on 21-may-2025 reporting that the issue occurred during a flush for a patient.The normal saline that was administered during the event was not an icu medical product.No one was harmed during the event; however, there was a delay in therapy.
Additional Manufacturer Narrative
Received one used ch-13 chemoclave bag spike with additive port for inspection.As received, there were no defects or anomalies noted.Fluid was attempted to prime through the chemoclave side port.There was no flow.The chemoclave was disassembled.There were no defects or anomalies initially noted that would cause an occlusion.The ch-13 was disassembled further to view the fluid path on the side port and bag spike lumen.The fluid path fluoresced under uv light, indicative of errant solvent.The reported complaint of no flow can be confirmed.The probable cause is due to errant solvent applied during manual assembly process of manufacturing.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in b5 - describe event or problem, h6 health effect - impact code and h7 - if remedial action initiated null.
Event or Problem Description
The event involved a chemoclave® bag spike with additive port where the reporter stated that they were unable to push normal saline flush through chemoclave as if it was clogged.There was patient involvement, a delay in therapy but no one was harmed as a result of this event.
Additional Manufacturer Narrative
It is reported that device has been received, however, investigation has not been completed.

• Brand Name: CHEMOCLAVE® BAG SPIKE WITH ADDITIVE PORT
• 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: 22238589
• Report Number: 9617594-2025-01271
• Device Sequence Number: 21118912
• Product Code: ONB
• UDI-Device Identifier: 00840619023737
• UDI-Public: (01)00840619023737(17)291101(10)14200059
• 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): 07/17/2025

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: CH-13
• Device Lot Number: 14200059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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: NORMAL SALINE (MANUFACTURER UNKNOWN)
• Patient Sex: Unknown