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	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A clave® connector reportedly leaked an unspecified fluid around the screw in piece of the connection/thread.They have 2 boxes of the said lot number that were affected, for which they have pulled the supply.Apparently, in ordering more clave connectors, they were still receiving some quantity/amount from the same lot number and encountered again that an iv site/hub was leaking on a patient as well.No one was harmed as a result of event.The set up was their normal insertion to the iv hub.The clave connector was replaced.No hole, cut, tears or any defect was noted.It was also stated that a mating device was attached and sometimes they observed this at the ct (computed tomography) connector, as the patient was on the ct table.
Additional Manufacturer Narrative
Devices was returned by the customer for evaluation; however, testing has not yet been completed.Section e initial reporter phone information: (b)(6).

• 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: 22545770
• Report Number: 9617594-2025-01498
• Device Sequence Number: 8727265
• Product Code: FPA
• UDI-Device Identifier: 00840619069896
• UDI-Public: (01)00840619069896(17)300101(10)14271804
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 07/18/2025

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: 14271804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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: UNSPECIFIED CT CONNECTOR, MFR UNK; UNSPECIFIED CT SCANNER AND CT TABLE, MFR UNK; UNSPECIFIED FLUID, MFR UNK; UNSPECIFIED IV DEVICE W/ HUB, MFR UNK
• Patient Sex: Unknown