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	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation; however, a lot number has been provided.A device history lot review is pending.(b)(6).
Event or Problem Description
The event involved a empty lifecare container 250 ml size where it was reported the empty bag has leakage.The set was used with erbitux.There were obvious defects noted on the tubing set like crack.There was no spillage or any drug exposure to patient or staff.The tubing was replaced and therapy resumed.The product was stored in the air-conditioned room in the hospital and was not exposed in extreme temperature condition.Sample video of the empty container connected to an iv set where fluids were leaking from the rubber connector where the spike was connected is available.There was no patient involvement and no patient harm.
Additional Manufacturer Narrative
A video was returned showing a container connected to an intravenous (iv) set, a leak can be seen coming from the administrative port.The leak appears to be coming from the side of the port, at the level of the piercing pin inserted.The complaint of leakage can be confirmed based on the video.The probable cause is due to a puncture with the piercing pin during use.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• 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: 21210824
• Report Number: 9615050-2025-00045
• Device Sequence Number: 3916404
• Product Code: KPE
• UDI-Device Identifier: 10887787006855
• UDI-Public: (01)10887787006855(17)260601(10)13641188
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

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 Expiration Date: 06/01/2026
• Device Catalogue Number: 079510470
• Device Lot Number: 13641188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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: ERBITUX, UNK MFR
• Patient Sex: Unknown