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

Catalog Number	011-MC100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.
Event or Problem Description
An email was received regarding a microclave clear connector alleging a leak during patient use.It was reported that the clave is connected via an elastomeric pump/autofuser to a central venous catheter.The symptoms appear after approximately 4 days.Symptoms of leakage, antibiotic deposits against the clave chamber, and condensation.There was no patient harm reported.
Additional Manufacturer Narrative
Updated information in sections b5, d1, d2, d4, and g4.D4: only di provided as lot number is unknown.
Event or Problem Description
Additional information received stating a defect occurred during administration/infusion and was noticed when disconnecting the autofuser.It was therefore replaced prematurely.The defect was noted in three different patients, all receiving flucloxacillin therapy.This report captures 1 of the 3 patients.
Additional Manufacturer Narrative
A device history review could not be completed due to the unknown lot number.Corrected information in h6.
Event or Problem Description
This report is for patient 2 of 3.

• Brand Name: MICROCLAVE® CLEAR CONNECTOR
• Common Device Name: SET, ADMINISTRATION
• 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: 23842723
• Report Number: 9617594-2025-02316
• Device Sequence Number: 13251394
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: 00840619042509
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 01/09/2026

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
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 12/19/2025; 12/30/2025
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 12/29/2025; 01/08/2026
• 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: FLUCLOXACILLIN ANTIBIOTICS, UNK MFR.
• Patient Sex: Unknown