MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOCLAVE® BAG SPIKE; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH-10
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Event or Problem Description
The event occurred on an unspecified date and involved a chemoclave® bag spike.The report states that when the iv tubing or needleless connector disconnected from spiros that was attached on an ambulatory infusion pump tubing, the spiros supposedly to shut off completely to prevent any fluid from escaping.There was no report of any human harm.
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Updated information in b5.
Event or Problem Description
An update has been made to the event description.¿ the product used for maximum of 2 hours before the issue occurred.¿ there was patient involvement.¿ there was no patient harm.
Additional Manufacturer Narrative
Corrected information can be found in section h6 type of investigation codes.
Additional Manufacturer Narrative
Corrected information can be found in section b, b3 - date of event and e4 - initial report sent to fda.

• Brand Name: CHEMOCLAVE® 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: 24259665
• Report Number: 9617594-2026-00067
• Device Sequence Number: 9575091
• Product Code: ONB
• UDI-Device Identifier: 00840619023676
• UDI-Public: (01)00840619023676(17)300801(10)14545770
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2026

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: CH-10
• Device Lot Number: 14545770
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 02/04/2026; 02/04/2026; 02/04/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/23/2026; 03/06/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• 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: AMBULATORY INFUSION PUMP, MFR UNK.; IV TUBING DEVICE, MFR UNK.
• Patient Sex: Unknown