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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a picture was returned showing the additive port stopper separated from the additive port subassembly.Additionally, received three (3) used list# 079510472 empty lifecare containers.As received a cut was observed on the upper corner of all three containers.The deformation of the area was observed to have smooth, straight edges, typical of a cut with a sharp object.The container was dimensionally measured, and a failure was found on the additive port assembly of one of the containers.The integrity of the ports on each of the containers was tested.No leakage was observed on any of the samples.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.The complaint loose port can be confirmed.The probable cause is unknown.
Event or Problem Description
An event involved an empty lifecare container 500 ml where the customer reported that the device had loose ports that could pop off and allowed the fluid to leak through.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 ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20792154
• Report Number: 9615050-2024-00826
• Device Sequence Number: 7980416
• 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