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

Catalog Number	MC100-GR
Medical Device Problem Codes	Difficult to Flush (1251); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of unable to flush 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.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event occurred on an unspecified date and involved a microclave® clear connector w/green ring.The reporter stated that the device will not draw or flush when connected to the vycon umbilical catheter and baxter stopcock during use on a baby patient.The event occurred pretty often now and then, multiple times.The line was placed in the patient, it was unable to flush and the clinician had to remove the adapter.There was delay in therapy since they had to try a few before it worked.However, there was no harm reported.

• Brand Name: MICROCLAVE® CLEAR CONNECTOR W/GREEN RING
• 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: 22327736
• Report Number: 9617594-2025-01344
• Device Sequence Number: 15528975
• Product Code: FPA
• UDI-Device Identifier: 00887709037182
• UDI-Public: (01)00887709037182(17)290701(10)14073812
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/25/2025

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: MC100-GR
• Device Lot Number: 14073812
• 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: 05/08/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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 STOPCOCK, MFR BAXTER; UNSPECIFIED UMBILICAL CATHETER, MFR VYCON
• Patient Sex: Unknown