MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, S; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	15247-28
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
Event or Problem Description
The event involved a primary plum set, clave secondary port, clave y-site, distal microbore tubing, secure lock, 104 inch where it was reported there were 4 devices that leaked.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Additional Manufacturer Narrative
The following was returned by the customer for complaint investigation: -one used list #15247-28, primary plum set as received, there was no physical damage or other anomalies observed on the returned device.There was some fluid residuals observed.The filter vent juncture was air leak tested with the cap closed, leakage was observed.The filter vent was pressure tested with the vent cap open, and leaking was observed.The customer complaint of tubing lines leaking was confirmed.The 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.Corrected information can be found in e3 - initial reporter occupation.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, S
• 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: 22064797
• Report Number: 9615050-2025-00242
• Device Sequence Number: 12724976
• Product Code: FPA
• UDI-Device Identifier: 00887709102057
• UDI-Public: (01)00887709102057(17)271101(10)14217614
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 15247-28
• Device Lot Number: 14217614
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: VANILLA TPN, CAPS.
• Patient Sex: Unknown