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	01/08/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A complaint with received a complaint regarding empty lifecare container 250 ml size in which it was stated the preparation for fentanyl (batch 50632 ) was inspected and particulate matter was found in the lifecare container.There was no patient involvement.
Additional Manufacturer Narrative
Received five used list #079510471, empty lifecare container 100 ml size and three 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 photos from the customer of various bags with possible particulates circled by the customer with written descriptions.The three 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 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 bags.The samples were sent for an ftir 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 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 manufacturing teams implemented process enhancements and inspection improvements to further reduce the potential for particulate introduction.Corrected information can be found in d10 concomitant product.

• 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: 24395265
• Report Number: 9615050-2026-00103
• Device Sequence Number: 15598479
• Product Code: KPE
• UDI-Device Identifier: 10887787006831
• UDI-Public: (01)10887787006831(17)280801(10)14445241
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2026

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: 14445241
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 05/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• 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 (BATCH 50660), MFR UNK
• Patient Sex: Unknown