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 Codes	Fluid/Blood Leak (1250); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of a stopcock issue could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.No lot received for a device history record review.Section e additional contact: (b)(6).
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a clave¿ connector.When pushing adenosine through an unspecified 3-way stopcock into a line with clave in between, the device reportedly malfunctioned by either: 1.Squirting the fluid out at the connection site where the stopcock entered the clave or, 2.They couldn't push the fluid in at all, meeting resistance.It appeared as through the center of the clave did not line up well with the opening of the stopcock.The work around discovered was to remove the clave and connect the stopcock directing onto the line prior to administering the adenosine.There was no issue or concern with the unspecified 3-way stopcock (mating device).No injuries or adverse event.There was an unspecified delay in therapy, though brief and unlikely to have caused negative clinical impact to the patients.This emdr reflects 10 occurrences of same or similar events.

• 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: 22038637
• Report Number: 9617594-2025-01028
• Device Sequence Number: 20868486
• Product Code: FPA
• UDI-Device Identifier: 00840619069896
• UDI-Public: 00840619069896
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ADENOSINE, MFR UNK; UNSPECIFIED 3-WAY STOPCOCK, MFR UNK; UNSPECIFIED IV LINE, MFR UNK
• Patient Sex: Unknown