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

Catalog Number	079510471
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and 01 jan 2025 has been used as a placeholder.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding an empty lifecare container 1000 ml size that experienced particulate matter.Report stated that they have been monitoring the instances of particles found in the icu medical bags after compounding for many months.It has typically been a very low level, a few bags every few batches compounded would have tiny particles that the visual inspector would catch after compounding.However, recently there has been a large increase in particles.This leads to rejection of the bag of compounded medicine.Sample video provided showing the instances of particles found.There was no patient involvement.
Additional Manufacturer Narrative
One photo and four videos were provided for evaluation; photo and videos confirm the complaint of tiny particles that the visual inspector would catch after compounding.No 079510471 bag samples were provided for evaluation.The reported complaint can be confirmed from the photo and videos provided.The probable cause is unknown without the return of the failed product.The device history record was reviewed, no relevant nonconformities observed that would have contributed to this 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 22790 ; CS 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21940015
• Report Number: 9615050-2025-00200
• Device Sequence Number: 8553693
• Product Code: KPE
• UDI-Device Identifier: 10887787006831
• UDI-Public: (01)10887787006831(17)271001(10)14195237
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

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: 14195237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2024
• 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
• Patient Sex: Unknown