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	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.Additional contact information: (b)(6).
Event or Problem Description
The event involved a chemoclave vented bag spike, and it was reported that the chemoclave is broken between blue and white junction.There was no bleed back reported.Herceptin and no concomitant device were involved.There was no delay in critical therapy.There was patient involvement, and no patient harm.
Additional Manufacturer Narrative
Photos were provided showing the chemoclave separated from the bag spike.The male luer of the chemoclave looked to be bonded inside of the bag spike and had broken off.The reported complaint can be confirmed.The probable cause is due to an unintentional bending force during use.The dhr was reviewed, and no nonconformities were found that would have led to the reported complaint.Updated information in d9.

• 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: 23653357
• Report Number: 9617594-2025-02225
• Device Sequence Number: 14645074
• Product Code: ONB
• UDI-Device Identifier: 00840619023751
• UDI-Public: (01)00840619023751(17)300501(10)14417215
• 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): 12/31/2025

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: 14417215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2025
• 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: HERCEPTIN, UNK MFR.
• Patient Sex: Unknown