MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. EMPTY LIFECARE CONTAINER 250ML; CONTAINER, I.V.

Catalog Number	079510422
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received on november 25, 2019.The investigation is not yet complete.
Event or Problem Description
The event involved an empty lifecare 250 ml container that the customer reported during preparation the officer noticed the presence of a contaminant inside the bag.There was no patient involvement.
Additional Manufacturer Narrative
H10: received one unused list# 079510422, empty container.The complaint of particulates inside the 079510422 empty lifecare container can be confirmed.As received there were reddish powder like residuals inside the empty lifecare container.The sample was not adequate enough to perform an ft-ir on.The probable cause and the origin of the residual is unknown.A batch record review was performed to lot# 929175h, list# 07951-0422 and no discrepancies that may have contributed to a complaint of this nature were found.

• Brand Name: EMPTY LIFECARE CONTAINER 250ML
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9402688
• Report Number: 9615050-2019-00465
• Device Sequence Number: 16795939
• Product Code: KPE
• UDI-Device Identifier: 00887787006858
• UDI-Public: (01)00887787006858(17)210801(10)929175H
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K771228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2019

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: 08/01/2021
• Device Catalogue Number: 079510422
• Device Lot Number: 929175H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1