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	01/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation, however, investigation is not yet complete.
Event or Problem Description
The event involved a to 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig), ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing where the customer reported that the patient rang call light and stated that her iv site was leaking blood.The nurse entered the room and removed sterile cover; the iv site was not leaking but it was noted that the blood was coming out of the top part of the j-loop.The nurse checked to make sure that the j-loop was tightened all the way, and it was.The j-loop was replaced, the area was cleaned and dressing was replaced.The event occurred in the emergency department during patient use; the product was in contact with bodily fluids and was not in contact with a hazardous agent.There was patient involvement but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
One (1) used.List #mc33038, 7" was returned for evaluation.As received, no physical damage or abnormality, only an unknown solution residual was observed.No mating device was returned for evaluation.The returned set was tested as per procedure and no anomalies, occlusions, or leaks were observed.The female and male luer were found to be iso compliant.Complaints of backflow of fluid can be confirmed, based on the unknown solution residual.However, without the return of the used mating device, a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• 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 ; CS 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21340467
• Report Number: 9617594-2025-00247
• Device Sequence Number: 20947303
• Product Code: FPA
• UDI-Device Identifier: 00887709037281
• UDI-Public: (01)00887709037281(17)290701(10)14093005
• 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): 03/10/2025

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: 14093005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 02/08/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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 Sex: Unknown