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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE 2000 ML TPN BAG SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE ¿ ROUND LAKE 2000 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938740
Device Problems Cap (424); Fluid Leak (1250); Material Perforation (2205)
Patient Problem No Patient Involvement (2645)
Event Date 04/03/2017
Event Type  Malfunction  
Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a 2000ml exactamix, eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag had a pin-sized hole along the seam. This was identified during an unspecified process step. There was no patient involvement. No additional information is available.

 
Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

 
Manufacturer Narrative

Additional information : the actual device was not available; however, a photograph of the sample was provided for evaluation. Visual inspection of the photo revealed a leak from the spike port. The reported condition was verified. The cause of the condition could not be determined. This issue is being further investigated. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand Name2000 ML TPN BAG
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE ¿ ROUND LAKE
round lake IL
Manufacturer (Section G)
BAXTER HEALTHCARE ¿ ROUND LAKE
25212 w. illinois route 120
round lake IL 60073
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8218868
MDR Text Key132124855
Report Number1416980-2018-08194
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/20/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device EXPIRATION Date08/31/2019
Device Catalogue NumberH938740
Device LOT Number1180624
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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