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	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a microclave¿ clear connector where it was reported that the product was vented with a luer slip syringe, after connecting to the infusion the clave was no longer permeable.The status of the product at the time of event was during infusion.The operator vented the connector with a syringe.An iv was then connected, but the connector was not fully open, preventing the iv from flowing.There was patient involvement, there was delay in therapy, unknown adverse event and no harm was reported.
Additional Manufacturer Narrative
Received one used 011-mc100 microclave clear connector for inspection.No defects or anomalies noted.No mating device was returned for inspection.The microclave was primed with no restrictions in flow.The microclave was leak tested per product specifications.There was no leakage.The reported complaint was unable to be replicated or confirmed.The dhr was reviewed and no relevant nonconformities were found that would have led to the reported complaint.D9 - date returned to mfg: 12nov2025.Corrected information can be found in the following fields: d10 concomitant products.E3 - initial reporter occupation.E4 - initial report sent to fda.G2 - report source.H6 - health effect - impact code.

• 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: 23452985
• Report Number: 9617594-2025-02117
• Device Sequence Number: 9318473
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: (01)00840619042509(17)300201(10)14307636
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 011-MC100
• Device Lot Number: 14307636
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: LUER SLIP SYRINGE, MFR UNK.; UNSPECIFIED FLUID/INFUSATE, MFR UNK.; UNSPECIFIED IV LINE, MFR UNK.
• Patient Sex: Unknown