MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EMPTY LIFECARE CONTAINER 100 ML SIZE; CONTAINER, I.V.

Catalog Number	079510471
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested to be returned for investigation, however, it has not yet been received.
Event or Problem Description
The entire port of a empty lifecare container 100 ml size reportedly came out upon opening the bag and unspecified fluid/solution fell onto the floor.This product issue was noted when the staff went to open the access port for a patient's infusion.There was no report of any human harm.
Additional Manufacturer Narrative
Received two photos from the customer.One photo was of the infusion pump and one photo was of the empty lifecare container 100ml size.In the photo of the bag the port was separated from the bag and stuck on the used piercing pin.The complaint of leakage and separation can be confirmed.The probable cause cannot be determined without the return of the used set.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: EMPTY LIFECARE CONTAINER 100 ML SIZE
• Common Device Name: CONTAINER, I.V.
• 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: 23795468
• Report Number: 9615050-2025-00607
• Device Sequence Number: 5546582
• Product Code: KPE
• UDI-Device Identifier: 10887787006831
• UDI-Public: (01)10887787006831(17)280501(10)14338098
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K771228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 079510471
• Device Lot Number: 14338098
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2025
• 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: UNSPECIFIED FLUID/SOLUTION, MFR UNK.
• Patient Sex: Unknown