MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE¿ VENTED VIAL SPIKE, 20MM; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	011-CH-74S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a chemoclave vented vial spike in which it was reported that they have been experiencing leakage when drawing from vials equipped with this device.The pressure balancing does not work properly with the air intake, resulting in persistent pressure inside the vials.The status of the product at the time of event was during priming, there was unprotected chemo exposure for the health professional.The adverse operator consequences were not specified, and no medical or surgical intervention was required.There was no patient harm, but there was delay in critical therapy.
Additional Manufacturer Narrative
Investigation summary one (1) used.List #011-ch-74s, connected to, 0.9% sodium chloride 100ml vial and a used, 20ml syringe and seven (7) new.List #011-ch-74s, chemoclave¿ vented vial spike, 20mm were returned for evaluation.As received, when the syringe was disconnected the seal was stuck down.No additional damage or anomalies were noted.The used and the new samples were primed as procedure and no flow restriction was noted.The clave was dissembled and no anomality was noted.The id of the returned mating device was measured finding within specifications.Complaint of difficulty when drawing from vials equipped with the device cannot be confirmed or replicated.However, during the test stick down in the used sample was noted, when sample was inspected, nothing wrong was noted, the probable cause of the stick down is unknown.

• Brand Name: CHEMOCLAVE¿ VENTED VIAL SPIKE, 20MM
• 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: 23879375
• Report Number: 9617594-2025-02327
• Device Sequence Number: 21198396
• Product Code: ONB
• UDI-Device Identifier: 00887709014657
• UDI-Public: (01)00887709014657(17)300601(10)14469881
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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: 011-CH-74S
• Device Lot Number: 14469881
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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: UNSPECIFED CHEMO AND VIAL, MFR UNKNOWN
• Patient Sex: Unknown