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 Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending completion.
Event or Problem Description
The customer initially reported an issue with ch3187 (9617594-2025-02025-00) where the reported problem was leak of paclitaxel and cisplatin during infusion.However, the customer also returned a mating device sample from ch-14 and during inspection of the returned mating device sample, it was noted that the item was related to the customer¿s complaint of leakage found on ch3187.There was patient involvement but no patient harm.There was no delay in critical therapy.
Additional Manufacturer Narrative
One used bifuse add-on set connected to one (1) used ch-14 and various mating devices were returned for evaluation.No defects or anomalies were found on visual inspection.Upon functional testing the ch3187, ch-14, and mating devices were leak tested.There was leakage from the spiros connection to the ch-14.The ch-14 and spiros from the ch3187 were disconnected and a stick down was found on the chemoclave of the ch-14.The ch-14 was disassembled, and the seal was found to be torn.The probable cause is due to access with an incompatible mating device.The dfu (directions for use) states: "the clave/microclave connector is compatible with luers with an internal diameter (id) between 1.55 mm and 2.8 mm.The dhr (device history review) 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23596555
• Report Number: 9617594-2025-02187
• Device Sequence Number: 9381781
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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-14
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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: CH3187, ICU MEDICAL, INC.; CISPLATIN MFR UNK.; PACLITAXEL MR UNK.
• Patient Sex: Unknown