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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following was provided by the customer for complaint investigation: one used list #079510471, empty lifecare container 100 ml size; lot #13851012.As received, no damage or anomalies were observed.In attempts to replicate clinical use the 100ml bag was attempted to be filled with 100 ml of water using an icu medical-provided syringe.During the fill process, a leak was observed to be coming from bag at the seal.The seal was observed to be misaligned.The complaint of leakage can be confirmed.The probable cause of the leak is due to misaligned seal of the bag during manufacturing.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.D9: date returned to mfg: 07may2025.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Additional contact: (b)(6).
Event or Problem Description
The complaint/event involved an empty lifecare container 100 ml size that reportedly leaked an unspecified fluid from the side and that the top of the device/bag was also not sealed well.There was no report of any human harm.

• 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: 21878511
• Report Number: 9615050-2025-00191
• Device Sequence Number: 8742057
• Product Code: KPE
• UDI-Device Identifier: 10887787006855
• UDI-Public: (01)10887787006855(17)270101(10)13851012
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2025

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: 13851012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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: UNSPECIFIED FLUID OR DRUG, MFR UNK
• Patient Sex: Unknown