MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, PE LINED TUBING, 107 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142480489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received regarding a primary plumset, pe lined tubing, 107 inch that experienced leakage.It was stated in the report that there was a leakage even when the vent cover is properly sealed.There is two quantities affected and samples are returning for investigation.There was patient involvement but no patient harm.Event was noted during infusion.And the set was connected to an extended filter.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
Device received on 7/22/2025.Investigation summary: received one (1) used.Bag spike adapter with spiros attached to one (1) used.List #142480489, primary plumset.With one (1) used.List #unknown, stopcock and one (1) used 500 ml intravenous bag connected to one (1) used clave bag spike with one (1) used bag spike adapter with spiros connected to one (1) used.List #142480489, primary plumset.As received, the two (2) sample's filters were wetted out.No other damage or anomalies noted.The two (2) sets were leak tested per specifications and leakage was observed on two (2) sets.The complaint of a leakage from vent port can be confirmed on two (2) sets.The probable cause of leakage is due to a temporary or complete loss of hydrophobic properties of the filter material due to an infusate interaction during use.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUMSET, PE LINED TUBING, 107 INCH
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22454294
• Report Number: 9615050-2025-00332
• Device Sequence Number: 12832212
• Product Code: FPA
• UDI-Device Identifier: 10887787006183
• UDI-Public: (01)10887787006183(17)270601(10)13968858
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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: 142480489
• Device Lot Number: 13968858
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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