MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE® CONNECTOR MULTIDOSE VIAL ADAPTER; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	CV-100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone has an extension number (b)(6).The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event occurred on an unknown date involving a clave® connector multidose vial adapter where the customer reported that the device is defective, and it was leaking.It is unknown if the event had patient involvement or patient harm.
Additional Manufacturer Narrative
Thirty-five new cv-100 clave connector multidose vial adapters were returned for investigation.There were no visual anomalies or damage observed.Each of the thirty-five new cv-100 clave connector multidose vial adapters were functionally leak tested and no leakage was observed with any of the returned new cv-100 clave connector multidose vial adapters.The complaint was unable to be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CLAVE® CONNECTOR MULTIDOSE VIAL ADAPTER
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 18310521
• Report Number: 9617594-2023-01126
• Device Sequence Number: 6114842
• Product Code: FMI
• UDI-Device Identifier: 00840619046156
• UDI-Public: (01)00840619046156(17)280801(10)13715373
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934591
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2024

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: CV-100
• Device Lot Number: 13715373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2023
• Supplement Date Received by Manufacturer: 12/28/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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