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	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An email was received with an attached medwatch report number mw5184335 with regards to a primary plumset, 0.2 micron filter, clave y-site, pe lined tubing, 104 inch, in which it was reported that during the first dose of fam-trastuzumab deruxtecan infusion and after only 1.7ml infused of the primed volume a leak occurred at the filter site.There was patient involvement and no reported patient harm.
Additional Manufacturer Narrative
The device has been requested for evaluation- it has not been received.The investigation is pending.

• 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: 24772274
• Report Number: 9615050-2026-00218
• Device Sequence Number: 6065951
• Product Code: FPA
• UDI-Device Identifier: 10887787005971
• UDI-Public: (01)10887787005971(17)270501(10)13984986
• 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,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: 13984986
• 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: 03/20/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2024
• 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: FAM-TRASTUZUMAB DERUXTECAN, MFR UNKNOWN.
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Race: White