• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE CORPORATION 2000 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938740
Device Problems Clamp (757); Break (1069); Difficult to Open or Close (2921)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

This event occurred from (b)(6) 2020 up to present. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that there was difficulty in closing the clamps of an unspecified quantity of exactamix 2000 ml eva tpn bags. It was further reported that when closing the clamps, pieces of plastic break off inside the hood. This issue was identified during setup prior to patient use. There was no patient involvement. No additional information is available.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2000 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 Key10560751
MDR Text Key207749842
Report Number1416980-2020-05844
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,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/21/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberH938740
Device LOT Number60241135
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 Received09/21/2020
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 Initial

-
-