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	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4 and h4 the lot#, expiration date, and manufacture date are unknown.The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
A complaint was received regarding a primary plum set, clave secondary port, clave y-site, distal microbore tubing, secure lock, 104 inch that experienced leakage during use.The reporter stated that the iv tubing leaking from vent port.The event date was unknown.Status was unknown.The patient safety was issued and midas report was made.The iv tubing was in use on a patient when it was noted to be leaking from the vent port.The exact date of the incident was on (b)(6) 2025.The defect resulted in no harm to the patient but does pose a risk for infection as it was no longer a closed system.The sample is available for evaluation.Thus, there was patient involvement and no human harm reported.
Additional Manufacturer Narrative
One used device was received for evaluation on 06/26/2025.As received, the filter was wetted out.No other damage or anomalies noted.The set was leak tested per specifications and leakage was observed.The complaint of a leakage from vent port can be confirmed.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.Lot history review could not be conducted because no lot number(s) was/were identified.

• 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: 22414482
• Report Number: 9615050-2025-00328
• Device Sequence Number: 13210289
• Product Code: FPA
• UDI-Device Identifier: 00887709102057
• UDI-Public: 00887709102057
• 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): 09/03/2025

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: UNKNOWN
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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