MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142550489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.
Event or Problem Description
The event involved a primary plumset, 0.2 micron filter, clave y-site, pe lined tubing, 104 inch that there were 4 incidents of pe lined tubing used for taxol leaking from the back of the filter at the boise cic.The leaks were small but visible, with drops on the floor and noticed the drips on the filter within minutes after the infusion had started.The rn stopped the infusion, changed the tubing, and monitored the tubing to watch for a leak.Small drips were observed with the second set of tubing on the filter, and the rn stopped the infusion and again changed the tubing.The infusion was started a third time, with a new package of tubing.The rn observed for leaking and saw none.The patient received the chemotherapy.There was potential patient exposure to chemotherapy.A spill kit was used to clean chemo that leaked from the filter.There was not a critical delay, and no medical intervention was needed as the leak was visualized prior to patient contact.The medication involved was 170 mg at 6 mg per ml of paclitaxel that was being administered.The event occurred during infusion.There were patient involvement and no harm.

• Brand Name: PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 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: 25503187
• Report Number: 9615050-2026-00512
• Device Sequence Number: 10520114
• Product Code: FPA
• UDI-Device Identifier: 10887787005971
• UDI-Public: (01)10887787005971(17)281201(10)14632604
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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: 142550489
• Device Lot Number: 14632604
• 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: 05/26/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2026
• 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: PACLITAXEL; TAXOL
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 94 KG