MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE® CONNECTOR MULTI-DOSE VIAL ACCESS SPIKE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	MS990
Medical Device Problem Codes	Corroded (1131); Melted (1385); Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not known to be available for evaluation; however, it has been requested.The investigation is pending.
Event or Problem Description
The event involved a clave® connector multi-dose vial access spike where the customer reported that the item is corroded, it is melting plastic, and it happened multiple times.There was unknown patient involvement and unknown adverse events.
Additional Manufacturer Narrative
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.Lot history review could not be reviewed due to the unknown lot number.

• Brand Name: CLAVE® CONNECTOR MULTI-DOSE VIAL ACCESS SPIKE
• 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21378745
• Report Number: 9617594-2025-00286
• Device Sequence Number: 8598669
• Product Code: FMI
• UDI-Device Identifier: 00887709058415
• UDI-Public: 00887709058415
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2025

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: MS990
• Device Lot Number: UNKNOWN
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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