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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION 500 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938738
Device Problems Cap (424); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 04/29/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was manufactured at one of the following manufacturing locations: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a white foreign material was observed on the fill port cap of twenty-four (24) 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags. This issue was identified prior to use. 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 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 Key10083117
MDR Text Key191836777
Report Number1416980-2020-02883
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 07/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberH938738
Device LOT Number60185719
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/03/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2020
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 Unkown

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