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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 250 ML TPN BAG SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION 250 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938737
Device Problems Clamp (757); Difficult to Open or Close (2921)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that the clamp of a 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was difficult to close. This issues was identified during setup and preparation prior to patient use. There was no patient involvement. No additional information is available.

 
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Brand Name250 ML TPN BAG
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
AVAILMED
c. industrial lt. 001 mz. 105
no 20905 int a, col cd ind.
tijuana, baja california 22444
MX 22444
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key10609464
MDR Text Key209259665
Report Number1416980-2020-06101
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)Y
Reporter Country CodeCA
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 09/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberH938737
Device LOT Number60246747
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2020
Is this a Reprocessed and Reused Single-Use Device? No

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