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	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved micro clave clear connector.It was reported that the silicone seal at the connection point inside the housing became jammed, obstructing the flow path and preventing the iv from entering.There was patient involvement but no harm.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.Reporter postal code: (b)(6).E1 - initial reporter phone: (b)(6).E1 - initial reporter email: (b)(6).

• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50803794
• Report Number: 9617594-2026-01290
• Device Sequence Number: 10575981
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 08/31/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: crystalloid, unk mfr
• Patient Sex: Unknown