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	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been reported available for return; however, it is yet to be received.
Event or Problem Description
The event involved a microclave¿ clear connector.The reporter stated that the biomedical syringes were being pushed out by the microclave.They stated that during use, the microclave no longer performed the proper locking mechanism that it always used to, and that it is now necessary to maintain all the pressure in the patient's line through the microclave for drug administration.The reporter stated that the syringes disconnected even after performing the quarter turn.No medication was used at the time of the event.There was patient involvement, a delay in therapy, however there was no adverse event and harm as result of this event.
Additional Manufacturer Narrative
The photo returned showed the microclave and syringe packaging.No defects or anomalies noted.Received one (1) opened/unused 011-mc100 and one (1) new 011-mc100 microclave for inspection.No defects or anomalies noted.No mating devices returned for inspection.An icu medical provided male and female luer were used to connect to both sides of microclave.There were no issues in connecting or disconnecting.The connections were secure with no propensity to disconnect.The reported complaint could not be confirmed.Without the return of the mating device, a comprehensive failure investigation cannot be performed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• 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: 22215811
• Report Number: 9617594-2025-01263
• Device Sequence Number: 20997518
• Product Code: FPA
• UDI-Device Identifier: 00840619042509
• UDI-Public: (01)00840619042509(17)290701(10)14079284
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 14079284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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: BIOMEDICAL SYRINGES (MANUFACTURER UNKNOWN).
• Patient Sex: Unknown