MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 7" (18 CM) APPX 0.46 ML, PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE®; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MC33327
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A medsun/medwatch report #mw5167729 received on 27-mar-2025 stating that while starting an iv, the j-loop was leaking an unspecified fluid.All pieces were attached appropriately, and no cracks noted.Additional event information obtained from the user facility medwatch (ufmw) form: initial reporter asked to remain confidential.The suspect medical device is 7" (18cm) appx 0.41 ml, pressure infusion (400psig) ext set w remv microclave clear, purple clamp, luer lock.The medwatch report indicates that an unspecified intervention was required.
Additional Manufacturer Narrative
The device is not available for complaint investigation.A review of the device history record is pending.
Additional Manufacturer Narrative
Corrected information can be found in h5 - labeled for single use and h6 health effect - impact code.
Additional Manufacturer Narrative
Investigation summary: the complaint could not be confirmed by 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 record was reviewed and no nonconformities were found that would have led to the reported complaint.

• Brand Name: 7" (18 CM) APPX 0.46 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: 21899708
• Report Number: 9617594-2025-00822
• Device Sequence Number: 11777009
• Product Code: FPA
• UDI-Device Identifier: 00887709037762
• UDI-Public: (01)00887709037762(17)290201(10)13906134
• Combination Product (Y/N): N
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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: MC33327
• Device Lot Number: 13906134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 03/27/2025; 04/29/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 04/24/2025; 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• 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: UNSPECIFIED FLUID/INFUSATE, MFR UNK.
• Patient Age: 76 YR
• Patient Sex: Female