MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EMPTY LIFECARE CONTAINER 500 ML SIZE; CONTAINER, I.V.

Catalog Number	079510472
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a picture was returned showing a drop of fluid at the additive port junction.Additionally received one (1) used list# 079510472 empty lifecare container.The integrity of the container was tested and a leak was observed at the junction between the additive port subassembly and the port.Observation of the junction under uv light confirmed a solvent channel between the port and additive port assembly junction.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.The complaint of leakage can be confirmed.The probable cause is due to a solvent application error in costa rica.
Event or Problem Description
The event involved an empty lifecare container 500 ml where the customer reported that there was a leak at the injection port.There was no controlled substance inside.There was unknown patient involvement and unknown human harm.

• Brand Name: EMPTY LIFECARE CONTAINER 500 ML SIZE
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20792674
• Report Number: 9615050-2024-00825
• Device Sequence Number: 20806818
• Product Code: KPE
• UDI-Device Identifier: 10887787006824
• UDI-Public: (01)10887787006824(17)270101(10)13870447
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2024

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: 079510472
• Device Lot Number: 13870447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2024
• 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