• 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 - ROUND LAKE 250 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 - ROUND LAKE 250 ML TPN BAG SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938737
Device Problems Cap (424); Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The event occurred on an unspecified date in 2019. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag had a damaged fill port connector cover. This was identified prior to patient use. There was no patient involvement. No additional information is available.

 
Manufacturer Narrative

The actual sample was received for evaluation. Unaided visual inspection was performed which revealed damage to the fill port connector cap. The reported problem was verified during initial inspection. The cause of the reported condition was not determined. No functional testing was performed for this complaint. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name250 ML TPN BAG
Type of DeviceSET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE - ROUND LAKE
round lake IL
Manufacturer (Section G)
BAXTER HEALTHCARE - ROUND LAKE
25212 w. illinois route 120
round lake IL 60073
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9204897
MDR Text Key163194673
Report Number1416980-2019-05680
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeBR
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 11/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2020
Device Catalogue NumberH938737
Device LOT Number1232123
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/10/2019
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/22/2019
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

-
-