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	02/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Event occurred regarding an empty lifecare container 100 ml size where they reported that they have been seeing fiber like material floating in post-production product.Premixed drugs they are manufacturing - fentanyl, ketamine, hydromorphone.They have not had any incidents with patients.
Additional Manufacturer Narrative
B3 - date of event - the date of event is unknown, and (b)(6) 2026 has been used as a placeholder.The device has been received for evaluation.The investigation is pending completion.
Additional Manufacturer Narrative
Received five (5) used.List #079510471, empty lifecare container 100 ml size and three (3) opened/unused.List #079510471, empty lifecare container 100 ml size.As received, no damage or anomalies noted.The bags were examined under bright light and no evidence of particulates was observed.Received fifteen (15) photos from the customer of various bags with possible particulates circled by the customer with written descriptions.The three (3) empty bags were filled with sterile water using icu medical provided materials which included a plum set, a sterile water bag, a ch-10, and a spiros to replicate the bags being full to check for particulates.Under bright lights no particulates were observed.The fluid from the eight (8) total bags was flushed and collected in a vacuum filtration system.The filter paper was examined under a microscope at 10x magnification to check for particulates from the bag and fluid.There were no residual particles on the filter paper on eight (8) bags.The samples were sent to austin for ftir (fourier transform infrared) analysis.The analysis showed that particulate matter was present on the filter paper when observed under higher magnification.The particulate matter observed were composed of cellulose and oleamide.The complaint of particulate matter can be confirmed.Particulate matter identified during the investigation was consistent with cellulose-based fibers and oleamide materials commonly associated with packaging and polymer processing aids.Based on the available information, the most probable source is related to environmental or material handling factors rather than a specific manufacturing defect.The costa rica and austin teams implemented process enhancements and inspection improvements to further reduce the potential for particulate introduction.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: 24437587
• Report Number: 9615050-2026-00126
• Device Sequence Number: 13353210
• Product Code: KPE
• UDI-Device Identifier: 10887787006831
• UDI-Public: (01)10887787006831(17)281001(10)14482697
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

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: 14482697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2025
• 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: FENTANYL, MFR UNKNOWN.; HYDROMORPHONE. MFR UNKNOWN.; KETAMINE, MFR UNKNOWN.
• Patient Sex: Unknown