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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation: it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a chemoclave vented bag spike where it was stated in the report that chemo drug (bendamustine) leakage from blue and white junction during infusion.There was no bleedback reported.The product is not a biohazard, and the device was not reprocessed/re-sterilized.There was patient involvement but no patient harm.There was no delay in critical therapy.
Additional Manufacturer Narrative
One used chemoclave® vented bag spike; connected to a 0.9% norm-saline 250ml bag, one used, bag spike adaptor w/ spiros and one used extension set were returned for evaluation.The device was visually inspected, it was noted that the spike was broken off and separated from the clave, some marks suggesting a twist bending force was applied.The complaint of leaks can be confirmed, based on the condition that sample was returned for evaluation.The probable cause is typical due to an unintentional twisting force applied during use.D9 - date returned to mfg: 12/4/2025.

• 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: 23659501
• Report Number: 9617594-2025-02230
• Device Sequence Number: 10027483
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 11/26/2025
• Supplement Report FDA Received Date: 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2025
• 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: BENDAMUSTINE, MFR UNKNOWN.
• Patient Sex: Unknown