MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE® CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	C1000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a clave¿ connector that experienced leakage.The reporter stated when the product c1000 was connected to ch2000s-c it was leaking chemotherapy around the luer threads of the c1000.This event happened several times with the same lot number.He also confirmed that the ch2000s-c was not having an issue and only the c1000 was experiencing an issue.There was unknown patient involvement.
Additional Manufacturer Narrative
The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Investigation summary: the reported complaint of a leak could not be confirmed.Without the return of the sample or a photo/video a comprehensive review could not be performed and a probable cause could not be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CLAVE® CONNECTOR
• 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: 22470384
• Report Number: 9617594-2025-01430
• Device Sequence Number: 20856471
• Product Code: FPA
• UDI-Device Identifier: 00840619069896
• UDI-Public: (01)00840619069896(17)300101(10)14295015
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K970855
• 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
• Report Date (Section B): 08/11/2025

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: C1000
• Device Lot Number: 14295015
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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: SPINNING SPIROS¿ ADAPTER, CH2000S-C, ICU MEDICAL.
• Patient Sex: Unknown