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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that, on an unspecified date in late april, a chemoclave¿ bag spike with additive port, chemoclave¿ generated a leak during patient use.The reporter stated that there have been events of stick down and leaks.There was no patient harm reported.
Additional Manufacturer Narrative
Investigation summary received one (1) used ch3955 chemoclave bag spike with additive port connected to various mating devices and one (1) new ch3955 for inspection.One (1) of the claves on the used ch3955 was stuck down.No defects or anomalies noted on the new ch3955.The stuck down clave was disassembled, and the internal spike was found to be bent and broken.The returned spiros was used to connect to each of the other claves on the used and new ch3955.There were no other stick downs.The reported complaint can be confirmed.The probable cause is due to a salt lake city molding defect.The device history was reviewed and no relevant nonconformities were found that would have led to the reported complaint.A corrective and preventative action (capa) plan has been implemented to address the identified issue.The outcome of the capa is currently under evaluation and is not yet finalized.
Additional Manufacturer Narrative
Received one (1) used ch3955 chemoclave bag spike with additive port connected to various mating devices and one (1) new ch3955 for inspection.One (1) of the claves on the used ch3955 was stuck down.No defects or anomalies noted on the new ch3955.The stuck-down clave was disassembled, and the internal spike was found to be bent and broken.The returned spiros was used to connect to each of the other claves on the used and new ch3955.There were no other stick downs.The reported complaint can be confirmed.The probable cause is due to a salt lake city molding defect.The device history review (dhr) was performed and no relevant nonconformities were found that would have led to the reported complaint.

• 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: 22196010
• Report Number: 9617594-2025-01235
• Device Sequence Number: 13068239
• Product Code: FPA
• UDI-Device Identifier: 00887709098305
• UDI-Public: 00887709098305
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 09/09/2025
• Initial Report FDA Received Date: 06/12/2025
• Supplement Report FDA Received Date: 08/15/2025; 10/03/2025
• 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
• Patient Sex: Unknown