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	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - date of birth - the patients age was used to approximate the date of birth as (b)(6) 1982.Investigation summary: the complaint of leaks on item mc33038 cannot be confirmed.Since no product samples, pictures, or videos were received for investigation.The device history record for lot# was reviewed, and no non-conformities were found that would have led to the reported condition on the complaint.Without the return of the used sample, a comprehensive failure investigation cannot be performed, and probable cause cannot be determined.
Event or Problem Description
A complaint was received regarding a 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing that experenced leakage.Report 1 of 2.Medwatch report #mw5166363 and mw5166364 received on 03-mar-2025 stated that when changed piv (peripheral intravenous line), j-loop flushed without issue.Put dressing on site was clean dry and intact.Noted pink drainage on one side of dressing, flushed again and noted scant drainage under dressing.Took dressing off, noted j-loop secure to iv catheter, unable to see where leaking was from.Changed j-loop, initial flush prior to attaching to patient, no leak noted.Attached to catheter, noted scant leak.Changed j-loop again without continued leaking.Both (j-loops) which leaked are from icu medical.Additional event information obtained from ufmw: the report was completed by a risk manager.Initial reporter asked to remain confidential.The date of this report was on 12-feb-2025 and the date of event was on (b)(6) 2025.The patient involved is a 43yr old male non-hispanic white.The suspect medical device is 7" (18 cm) appx 0.30ml, smallbore pressure infusion (400psig) ext set w/remv microclave® clear, purple clamp, luer lock, non-dehp tubing with list number mc33038 and lot number 14163930, common device name set, administration, intravascular with expiration date 01-jan-2029.Outcomes attributed to adverse event: required intervention.Operator of the device is a health professional.This is a single use device that was not reprocessed.The device is not available for evaluation.No combination product.Type of event is serious injury.Health effect with clinical code is 2686: fluid discharge.

• 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: 21733432
• Report Number: 9617594-2025-00596
• Device Sequence Number: 8735017
• Product Code: FPA
• UDI-Device Identifier: 00887709037281
• UDI-Public: (01)00887709037281(17)291001(10)14163930
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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: 14163930
• 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: 03/03/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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: 43 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White