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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD 500 ML TPN BAG SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE - ENGLEWOOD 500 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938738
Device Problems Port (495); Detachment Of Device Component (1104); Fluid Leak (1250); Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 02/13/2018
Event Type  Malfunction  
Manufacturer Narrative

The device was returned and an evaluation is complete. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Visual inspection was performed and noted the add port cap and spike port cap were detached. Functional leak testing was performed by filling the bag with tap water. A leak was found at the spike port where the cap was detached. The reported issue was verified. The cause of the condition could not be determined. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

During evaluation of a returned 500ml exactamix eva tpn bag it was found that the spike port cap was detached. There was no patient involvement. No additional information is available.

 
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Brand Name500 ML TPN BAG
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE - ENGLEWOOD
englewood CO
Manufacturer (Section G)
BAXTER HEALTHCARE - ENGLEWOOD
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7402924
MDR Text Key104573953
Report Number1416980-2018-01907
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeCO
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date05/31/2020
Device Catalogue NumberH938738
Device LOT Number1234177
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/03/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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