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	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event involved primary plum set, 0.2-micron filter, clave y site, polyethylene lined tubing, secure lock, 104 inch it was reported that three taxol infusion sets leaked during administration.The affected sets were quarantined.Per rn staff, a few drops of fluid were observed on the on the taxol filter square portion.No patients have had direct exposures to the fluid drops, but there was a potential.This was discovered halfway through so set was exchanged and remaining infusion administered.There was patient involvement and no harm.
Additional Manufacturer Narrative
The device has been requested for evaluation; however, it has not yet been received.

• 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: 25562914
• Report Number: 9615050-2026-00583
• Device Sequence Number: 15971874
• Product Code: FPA
• UDI-Device Identifier: 10887787005971
• UDI-Public: (01)10887787005971(17)290301(10)14886524
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 06/19/2026

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: 14886524
• 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: 06/02/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2026
• 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: KADCYLA
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White