MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EMPTY LIFECARE CONTAINER 100 ML SIZE; CONTAINER, I.V.

Catalog Number	079510471
Medical Device Problem Codes	Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
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
A empty lifecare container 100 ml size that reportedly leaked water or air.Patient involvement is unknown but there was no patient harm/adverse event.
Additional Manufacturer Narrative
Device received on 07/22/2025.Correction b5 section.Investigation summary: received two (2) used.List #079510471, empty lifecare container 100 ml size for inspection.As received the two (2) bags had a v-shaped puncture above the secondary port, typical of a needle strike.None of the ports were observed to be loose.No additional damage or anomalies were observed.The two (2) bags were leak tested, and leakage was observed on the two (2) bags from the v-shaped puncture.The complaint of leakage can be confirmed on two (2) sets.The probable cause is due to a needle entering too far into the empty lifecare container through the injection port and striking the inside of the container.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
There were 2 incidents reported.

• 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: 22350269
• Report Number: 9615050-2025-00324
• Device Sequence Number: 8573532
• Product Code: KPE
• UDI-Device Identifier: 10887787006831
• UDI-Public: (01)10887787006831(17)270901(10)14148291
• 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): 09/08/2025

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: 079510471
• Device Lot Number: 14148291
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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