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

Catalog Number	011-MC100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Possible lots with associated manufacture and expiration dates: 13778914, manufacture date: 03 oct 2023, expiration date: 01 oct 2028, 14282404, manufacture date: 20 jan 2025 , expiration date: 01 jan 2030.Investigation summary: received one (1) used 011-mc100 microclave for inspection.The silicone plug was stuck down as received.Fluid residuals were observed inside of the internal spike.The reported complaint of restricted flow can be confirmed due to the dried-up residuals.The probable cause of the restricted flow and stick down is unknown.The possible lot numbers were reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Event or Problem Description
A patient reportedly bled through a microclave¿ clear connector during a ct contrast imaging test procedure at the location of the patient's cannula and the microclave.The pressure limit of 325 psi was exceeded (with no reason explained), and as a result, the injection speed decreased considerably and the imaging was not optimal.After the imaging, the patient bled through the microclave, it was then noticed that the rubber part of the microclave had sunk in.Also, at least on may 13, it was noticed that for several patients, the pressure limit had been exceeded for an unexplained reason, which is very rare.There was no patient harm reported.

• Brand Name: MICROCLAVE¿ CLEAR 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23354206
• Report Number: 9617594-2025-02021
• Device Sequence Number: 21104913
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: 00840619042509
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 02/17/2026

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: 011-MC100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: UNSPECIFIED CANNULA DEVICE, MFR UNK; UNSPECIFIED CONTRAST AGENT INJECTABLE, MFR UNK; UNSPECIFIED CT CONTRAST IMAGING MACHINE, MRF UNK
• Patient Sex: Unknown