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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 1000 ML TPN BAG SET, I.V. FLUID TRANSFER

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BAXTER HEALTHCARE CORPORATION 1000 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938739
Device Problems Cap (424); Port (495); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 07/09/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that white foreign material was observed in twenty (20) 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags. It was further reported that some of the foreign materials were found in the fluid path and cap. This issue was identified prior to patient use. There was no patient involvement. No additional information is available.

 
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Brand Name1000 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 Key10356679
MDR Text Key201396777
Report Number1416980-2020-04626
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)Y
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
Type of Report Initial,Followup
Report Date 09/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberH938739
Device LOT Number60203797
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/29/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2020
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 Initial

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