MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CLAVE¿ CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	11956
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	07/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Event occurred regarding a clave® connector where the customer reported that the central venous line at the connection for the pressor medication was broken.The customer reported an acute drop in blood pressure (specifics not provided) at 10:50am for a patient that is hemodynamically unstable in intensive care unit (icu) on pressor management and continuous veno-venous hemofiltration (cvvh).The customer stated that they adjusted the arterial blood pressure waveform as appropriate i.E., re-leveled, flushed, and re-zeroed but there was continued drop in blood pressure after adjustments.The patient continued to be alert and orientated.They adjusted the lines as needed and blood pressure medication reconnected, so the patient's blood pressure increased appropriately.
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Additional Manufacturer Narrative
Two used devices were retutned for evaluation; as received no visual damages or anomalies were observed.The reported complaint of a broken connection could not be confirmed.The returned samples were tested and met product specifications with no disconnections or leaks observed.Lot history review could not be conducted because no lot number(s) was/were identified.

• 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: 22841462
• Report Number: 9617594-2025-01700
• Device Sequence Number: 9580833
• Product Code: FPA
• UDI-Device Identifier: 00887709042193
• UDI-Public: 00887709042193
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: 11956
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/09/2025
• 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: CVVH, MFR UNKNOWN; PRESSOR, MFR UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown