Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ICU MEDICAL COSTA RICA LTD. PRIMARY PLUMSET, 0.2 MICRON FILTER, CLAVE Y-SITE, PE LINED TUBING, 104 INCH; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.Initial reporter (full) phone number: (b)(6).Additional reporter: (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 is one of 3 events/occurrences.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key25300477
Report Number9615050-2026-00315
Device Sequence Number9368458
Product Code FPA
UDI-Device Identifier10887787005971
UDI-Public10887787005971
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K141789
Number of Events Summarized1
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 Number142550489
Device Lot NumberUNKNOWN
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 Manufacturer06/05/2026
Initial Report FDA Received Date05/27/2026
Supplement Report FDA Received Date06/20/2026
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 Number1
Concomitant Medical Products
and Therapy/Usage Dates
TOTAL PARENTERAL NUTRITION (TPN), MFR UNK
Patient SexUnknown
-
-