MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. ChemoClave¿ Bag Spike with Additive Port, ChemoClave¿; Set, administration, intravascular

Catalog Number	CH3955
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a chemoclave bag spike with additive port, chemoclave reported that when spiking the ifosfamide bag to circle prime, the clave depressed and malfunctioned, and no fluid was able to leave the iv bag into the tubing.Pharmacy re-made the dose due to the spike malfunction, and the same thing happened a second time.The bag spike depressed too far, and no fluid was able to flow from the bag.The event occurred during patient use.There was a delay in therapy.There was patient involvement and no harm.
Additional Manufacturer Narrative
The device is not available for evaluation.A supplemental mdr will be submitted if any updates become available.

• Brand Name: ChemoClave¿ Bag Spike with Additive Port, ChemoClave¿
• Common Device Name: Set, administration, intravascular
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. De R.L. De C.V.; avenida cuarzo no. 250; ensenada, b.cfa. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50475541
• Report Number: 9617594-2026-01123
• Device Sequence Number: 13343156
• Product Code: FPA
• UDI-Device Identifier: 00887709098305
• UDI-Public: (01)00887709098305(17)310501(10)14971200
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: CH3955
• Device Lot Number: 14971200
• 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: 08/10/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2026
• 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
• Patient Sex: Unknown