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	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.(b)(6).
Event or Problem Description
On an unspecified date, a primary plumset, 0.2 micron filter, clave y-site, pe lined tubing, 104 inch reportedly leaked at the filter.During the evaluation of the newborn baby and its environment at the beginning of the shift, the nurse noticed that the sheet was soiled and wet.She then observed the leak at the filter.Then, the staff checked all the babies receiving total parenteral nutrition (tpn), since this filter is mandatory, and observed the same problem on three other circuits; 4 affected tubing devices.The babies were receiving nutrition (tpn), which was prepared once every 24 hours by the pharmacy.As a result, these babies did not receive their optimal nutrition for a few hours.Once there was a leak in the tubing, they replaced the solution in order to avoid any risk of infection.There was no report of any harm.This emdr reflects the third of 3 events/occurrences spanning two defective devices.

• 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: 25301466
• Report Number: 9615050-2026-00317
• Device Sequence Number: 9294208
• Product Code: FPA
• UDI-Device Identifier: 10887787005971
• UDI-Public: (01)10887787005971
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2026

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: 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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/20/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TOTAL PARENTERAL NUTRITION (TPN), MFR UNK
• Patient Sex: Unknown