MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.77 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC9004
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a 9" (23 cm) appx 0.77 ml, pressure infusion (400psig) ext set w/remv microclave¿ clear, clave¿ clear, clamp, rotating luer where we received a medwatch voluntary with mdr report mw5159531 where the report stated that a patient was brought in for angio, flushed iv- started angio, no contrast seen.They went to the check the patient, hub of new iv tubing poppoed off- contrast sprayed all over the patient, ct table and floor.They had to repeat trigger, this is the second time the user had experienced the problem.There was a 62-year-old black or african american female involved, unknown patient harm and unknown delay in therapy.
Additional Manufacturer Narrative
The device is available for evaluation- the investigation is pending.
Additional Manufacturer Narrative
The complaint could not be confirmed by the investigation.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 a cause cannot be determined.The device history review (dhr) was reviewed and no nonconformities were found that would have led to the reported complaint.
Additional Manufacturer Narrative
The device was received for evaluation o1/29/25.As received, the silicone plug on the y-clave was protruding from the housing.The reported complaint can be confirmed.The probable cause is due to a high pressure infusion being infused through the microclave instead of the y-clave during use.The dfu states: "for sets equipped with clave/microclave y site: prior to pressurizing, activate the slide clamp and give the pressure infusion through the clave/microclave y site." lot history review was conducted and no nonconformities were found that would have led to the reported complaint.Additional information d9.

• Brand Name: 9" (23 CM) APPX 0.77 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿
• 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: 20691598
• Report Number: 9617594-2024-01614
• Device Sequence Number: 7281749
• Product Code: FPA
• UDI-Device Identifier: 00887709039315
• UDI-Public: (01)00887709039315(17)290401(10)13987956
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2025

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: MC9004
• Device Lot Number: 13987956
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 02/25/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/20/2024; 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American