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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation however, it has not yet been received.
Event or Problem Description
The event involved a microclave clear connector where the customer reported that the microclave was connected to secondary line 011-ch3261 which creates an open system and there was a high risk chemo spill.Patient involvement was unknown, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The customer's complaint of leaks on item 011-mc100 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.The dhr review couldn't be performed due to the lot number for this complaint was unknown.

• 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: 24539887
• Report Number: 9617594-2026-00235
• Device Sequence Number: 21089306
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: (01)00840619042509
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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): 04/28/2026

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
• Device Lot Number: UNKNOWN
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 03/07/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 011-CH3261, ICU ADMIN SET; UNSPECIFIED CHEMOTHERAPY, MFR UNK
• Patient Sex: Unknown