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	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date and involved a microclave¿ clear connector where an event occurred in the intensive care unit (icu), where the nurse was unable to inject medication during cardiopulmonary resuscitation because the microclave clear was blocked.The type of venous tract involved said to be "vvc." the catheter was indeed permeable after the removal of the valve causing a permeable problem.The valve was not more than a week old.There was delay in processing but acceptable because defect of the material was perceived quickly.Harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation; a device history will be performed.
Additional Manufacturer Narrative
Received one used list# 011-mc100, microclave¿ clear connector: lot# 14282436.No visual damages or anomalies were observed.The reported complaint of an occlusion could not be confirmed.The returned sample was tested and met product specifications.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 25aug2025.Corrected/additional information received on 29jul2025 can be found in b5.Corrected information can be found in e3 - initial reporter occupation, h6 health effect - impact code and h6 component code.
Event or Problem Description
Additional information from the customer was received on 29-jul-2025 stating that the sample is a microclave clear valve that they currently keep in their office.The sample does not contain any dangerous material but it has nevertheless been connected to a central venous line and therefore, traces of blood are visible.No visible defects were noted on the microclave device.The patient recovered.The valve was changed immediately as it is impossible to inject otherwise.There was delay in processing but acceptable because defect of the material was perceived quickly.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22677127
• Report Number: 9617594-2025-01570
• Device Sequence Number: 18503502
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: (01)00840619042509(17)300101(10)14282436
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Nurse
• 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 011-MC100
• Device Lot Number: 14282436
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2025
• 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 MEDICATION, MFR UNK.
• Patient Sex: Unknown