MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EMPTY LIFECARE CONTAINER 250 ML SIZE; CONTAINER, I.V.

Catalog Number	079510470
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported interaction number (b)(4).It is unclear what this number is.B3 - date of event - the date of event is unknown, and 01 jan 2026 has been used as a placeholder.The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
An complaint with received a complaint regarding empty lifecare container 250 ml size in which it was stated the preparation for fentanyl (batch 49015) was inspected and particulate matter was found in the lifecare container.There was no patient involvement.An email with interaction number (b)(4) received a complaint regarding empty lifecare container 250 ml size with list number 079510470 and lot number 14035783.It was stated in the report that the fentanyl batch 48995 49015 49742 and 50481 have been seen for particulate matter.There was no patient involvement.
Additional Manufacturer Narrative
Investigation summary: 02/23/2026.Received four (4) photos of the bags.A circled particulate marked by the customer was observed in each photo.Whether the particulate is inside or outside or the bag or adhering to the surface cannot be determined.The complaint of particulate matter can be confirmed.The probable cause cannot be determined without the return of the used sample.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: EMPTY LIFECARE CONTAINER 250 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: 24394010
• Report Number: 9615050-2026-00097
• Device Sequence Number: 9862308
• Product Code: KPE
• UDI-Device Identifier: 10887787006855
• UDI-Public: (01)10887787006855(17)270801(10)14035783
• 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): 03/06/2026

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: 079510470
• Device Lot Number: 14035783
• Was Device Available for Evaluation?: No
• 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: 02/24/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/24/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FENTANYL BATCH 49015, MFR UNKNOWN.
• Patient Sex: Unknown