MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, POLYETHYLENE-LINED LIGHT RESISTANT TUBIN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	15339-28
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Event or Problem Description
The event involved a primary plum set where it was reported the iv tubing was leaking immediately after priming/hanging new line on 4/23.It was stated multiple lines have leaked on the unit.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
Investigation summary: received one (1) used, list #unknown, primary plum set w/ orange tubing.As received, no physical damage or other anomalies observed.There was some fluid residuals observed.The filter vent juncture was air leak tested with the cap closed, no leakage was observed.The filter vent was pressure tested with the vent cap open, leaking was observed.Confirmed customer complaint of tubing lines leaking.Probable cause is due to a loss of hydrophobic properties resulting from an infusate interaction during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, POLYETHYLENE-LINED LIGHT RESISTANT TUBIN
• 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: 22078085
• Report Number: 9615050-2025-00258
• Device Sequence Number: 15631064
• Product Code: FPA
• UDI-Device Identifier: 00887709102361
• UDI-Public: (01)00887709102361(17)280101(10)14205088
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 15339-28
• Device Lot Number: 14205088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2025
• 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: VANILLA TPN, CAPS.
• Patient Sex: Unknown