MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" (23 CM) APPX 0.67 ML, EXT SET PRESSURE INFUSION (400 PSIG) W/2 MICROCLAVE¿ CL; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC330623
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary received four (4) new mc330623 and one (1) used mc330623 for inspection.The seal was protruding from the proximal microclave of the used sample.No defects or anomalies noted on the new samples.A test pressure infusion was done on each sample.Each clamp failed and allowed fluid through.The seal protruded on three (3) of the new samples during the test.The reported complaint can be confirmed.The probable cause is unknown.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
Complaint email from (b)(6), supervisor of (b)(6) hospital was received with regards to a 9" (23 cm) appx 0.67 ml, ext set pressure infusion (400 psig) w/2 microclave clear, purple clamp, rotating luer where the reporter stated that the patient went to ct scan and when they came back, the iv tubing-rubber plug inside the microclave had prolapsed outside of the plastic microclave.The event occurred in emergency dept.At (b)(6).There was patient involvement but unknown adverse event.Unsure of how this occurred.There were no adverse event and no delay in therapy.

• Brand Name: 9" (23 CM) APPX 0.67 ML, EXT SET PRESSURE INFUSION (400 PSIG) W/2 MICROCLAVE¿ CL
• 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: 25266291
• Report Number: 9617594-2026-00488
• Device Sequence Number: 9758586
• Product Code: FPA
• UDI-Device Identifier: 00887709097667
• UDI-Public: (01)00887709097667(17)291101(10)14218591
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2026

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: MC330623
• Device Lot Number: 14218591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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 Sex: Unknown