MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" (15CM) APPX 0.49 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 4 CLAMPS; STOPCOCK, I.V. SET

Catalog Number	011-MC3323
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
The event involved a 6" (15cm) appx 0.49 ml smallbore trifuse ext set w/3 microclave¿ clear, 4 clamps, rotating luer.It was reported that the safety valve stayed open on an inadvertent disconnect allowing central venous access device (cvad) to be open to air.Someone became aware of the issue when the staff noticed that the valve was stuck down upon disconnection.Propofol and fentanyl were the medications being used on the patient at the time.There was an unspecified delay in therapy, however there was no adverse event/harm as a result of the reported event.
Additional Manufacturer Narrative
Investigation summary received two (2) used 011-mc3323 smallbore trifuse ext set w/3 microclaves for inspection.No defects or anomalies noted and no stick downs on the microclaves as received.Each syringe was connected to each microclave and disconnected.There were no stick downs.The set was leak tested per product specifications from each microclave.There was no leakage.The reported complaint was unable to be replicated or confirmed.The device history record was reviewed and no relevant nonconformities were found that would have led to the reported complaint.

• Brand Name: 6" (15CM) APPX 0.49 ML SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE¿ CLEAR, 4 CLAMPS
• Common Device Name: STOPCOCK, I.V. SET
• 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: 21599285
• Report Number: 9617594-2025-00466
• Device Sequence Number: 9035251
• Product Code: FMG
• UDI-Device Identifier: 00840619043247
• UDI-Public: (01)00840619043247(17)290801(10)14104622
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K964435
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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-MC3323
• Device Lot Number: 14104622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: FENTANYL, MFR UNK.; PROPOFOL, MFR UNK.; UNSPEC CENTRAL VENOUS ACCESS DEVICE, CVAD, MFR UNK.
• Patient Sex: Unknown