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

Catalog Number	MC100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One used device was received for evaluation on 3/9/2026 and received one photo from the customer showing the affected sample.The sample was observed to have fluid outside the seal.The reported complaint of the body filling with fluid could be confirmed.Residue was observed in the body of the microclave and outside the seal.However, the leak was unable to be replicated during testing.The probable cause of the leak is unknown.
Event or Problem Description
An event involved a microclave clear neutral connector with item number mc100 and unknown lot number.It was reported that microclave was attached to the fused extension piece (mc3302) of the ¿peripherally inserted central catheter (picc line)¿ line noted to be backup/filling with fluid.Photo of the defective item was provided.The event occurred in use for patient infusion via central line.There was patient involvement and no patient harm.

• Brand Name: MICROCLAVE¿ CLEAR NEUTRAL 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: 24988927
• Report Number: 9617594-2026-00407
• Device Sequence Number: 21449732
• Product Code: FPA
• UDI-Device Identifier: 00887709037151
• UDI-Public: (01)00887709037151
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K100434
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2026

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: MC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 04/24/2026
• 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
• Patient Sex: Unknown