MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. EMPTY LIFECARE CONTAINER 500 ML SIZE; CONTAINER, I.V.

Catalog Number	079510472
Medical Device Problem Codes	Contamination (1120); Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation but a lot history review will be conducted.
Event or Problem Description
The event was reported via a medsun medwatch uf/importer report # mw5168398 and mw5168399 and involved empty lifecare container 500 ml size.The customer reported that a compounded total parenteral nutrition (tpn) was being prepared using 500ml empty containers (single use bags).Upon final inspection of the compounded product, two different bags from the same icu medical package had a single small piece of clear plastic suspended in the solution (mw5168398).There is unknown patient involvement; harm was not reported as a consequence of this event.This is complaint 1 of 2.
Additional Manufacturer Narrative
No product samples, videos or photographs were returned for investigation.A probable cause cannot be identified based on the information that has been provided.Lot history review was conducted and there were no non-conformances found that would have contributed to the reported complaint.

• Brand Name: EMPTY LIFECARE CONTAINER 500 ML SIZE
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21997005
• Report Number: 9617594-2025-00945
• Device Sequence Number: 9484857
• Product Code: KPE
• UDI-Device Identifier: 10887787006824
• UDI-Public: (01)10887787006824(17)260501(10)13579470
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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 Expiration Date: 05/01/2026
• Device Catalogue Number: 079510472
• Device Lot Number: 13579470
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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