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	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received one used list#: 079510470, empty lifecare container 250 ml.As received, the open connector is not attached to the bag.Not sealed in the bag.Confirmed customer complaint of leaking, probable cause is assembly error during manufacturing.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.D9: date returned to mfg: 16may2025.Corrected information can be found in: section e (throughout), g2: report source, h6: health effect - clinical code, h6: health effect - impact code, h6: component code.Additional contact: (b)(6).
Event or Problem Description
A complaint was received regarding an empty lifecare container 250 ml size that experienced leakage.It was stated in the report that the pca bag is a bag that holds liquids, and the open connector is not attached to the bag, which resulted in a liquid leakage.The event occurred on 18-apr-2025.Patient involvement and patient adverse event are unknown.There is one quantity affected and one sample is returning for investigation.
Additional Manufacturer Narrative
The investigation is pending completion.Upon completion a supplemental mdr will be submitted.

• 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: 22039918
• Report Number: 9615050-2025-00232
• Device Sequence Number: 15673545
• Product Code: KPE
• UDI-Device Identifier: 10887787006855
• UDI-Public: (01)10887787006855(17)270801(10)14035783
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 079510470
• Device Lot Number: 14035783
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown