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	Chemical Exposure (2570)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.
Event or Problem Description
The event occurred on an unspecified date and involved a chemoclave¿ bag spike with additive port, chemoclave¿.It was reported that chemotherapy would not flow after it has been spiked by pharmacy, seeming like the vertical clave was compressed.Multiple events occurred throughout july and this week.The chemo did come into contact with the patient or healthcare provider.There was an unspecified delay in patient care; increased time/scrambling with nursing and pharmacy to re-spike the bag.The staff reported a safety concern with more manipulation trying to get it to work.Increase in central line access.There was no spill.The issue occurred during use on patients.There was no adverse event or human harm.
Additional Manufacturer Narrative
The complaint could not be confirmed by the investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The device history review (dhr) could not be reviewed due to the unknown lot number.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22877241
• Report Number: 9617594-2025-01732
• Device Sequence Number: 16058392
• Product Code: FPA
• UDI-Device Identifier: 00887709098305
• UDI-Public: 00887709098305
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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: CH3955
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 10/01/2025
• 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: UNSPECIFIED CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown