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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 Date 08/25/2020
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). (b)(4). Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that the clear clamps of an unknown number of 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were difficult to close. This issue was identified 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 Key10556890
MDR Text Key207707345
Report Number1416980-2020-05835
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)Y
Reporter Country CodeUS
PMA/PMN NumberK900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberH938737
Device LOT Number60250629
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/11/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2020
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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