MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33038
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
It was reported that, on an unspecified date in june, a 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing generated a leak during patient use.The report stated that the intravenous (iv) was patent, and when they went to flush the line, there was a notable leak at the site of the tubing meeting the needleless end cap.There was patient involvement, no patient harm.
Additional Manufacturer Narrative
Received one (1) used mc33038 smallbore pressure infusion ext set for inspection.A crack was observed on the female luer.The reported complaint of leakage can be confirmed due to the crack found.The probable cause is due to a material issue with a vendor-supplied part.The device history review (dhr) was performed, and no nonconformities were found that would have led to the reported complaint.D9 - date returned to mfg: 7/31/2025.

• Brand Name: 7" (18 CM) APPX 0.30ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MIC
• 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: 22587040
• Report Number: 9617594-2025-01524
• Device Sequence Number: 9282859
• Product Code: FPA
• UDI-Device Identifier: 00887709037281
• UDI-Public: (01)00887709037281(17)290801(10)14121331
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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: MC33038
• Device Lot Number: 14121331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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