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	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation; however, a lot number has been provided.A device history lot review is pending.
Event or Problem Description
Event involved a clave¿ connector where they reported that clave connecter blue knobs leaks.They said a few incidents have occurred within the past month.The reporter stated that the hub becomes stuck unpredictably and leaks out fluid during infusion.The procedures were completed, and the tests were still in diagnostic level so there was no delay in diagnosis or treatment.The clave which was directly connected to the patients iv.Was previously attached to stop-cock/tubing series for morning stress test and was then disconnected for rest test when the tracer leakage occurred.They stated that the clave was not accessed with a blunt or sharp but was only accessed within the target area.The clave site where the leak noted was at peripheral iv - left acf.The syringe was directly attached to clave.No impact on the patient or healthcare provider, only a small drop was spilled on the patient's arm but was cleaned with an alcohol swab and the supplies were placed in radioactive garbage afterwards.The majority of the dose went through the iv and was collected in the patient's heart, so the patient did not receive any additional radiation as a result.The radioactive spill was cleaned up per facility protocol and no spill kit was necessary as the tracer did not contaminate any external surfaces.The leakage occurred a few seconds into the injection, when most of the tracer had been injected already so the patient still received the same amount of radiation as was ordered for their test originally.
Additional Manufacturer Narrative
Investigation summary.The complaint could not be confirmed by 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 was reviewed, and no nonconformities were found that would have led 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: 22668143
• Report Number: 9617594-2025-01565
• Device Sequence Number: 7440178
• Product Code: FPA
• UDI-Device Identifier: 00840619069896
• UDI-Public: (01)00840619069896(17)290801(10)14105230
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 14105230
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2024
• 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: RADIOACTIVE DRUG, UNKNOWN MFR.
• Patient Sex: Unknown