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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 Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Event date: the event occurred on an unspecified date in 2019.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 three (3) 500ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags were defective.The defect was further described as a leak coming from an unknown location.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
500 ML TPN BAG
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10588369
MDR Text Key208632745
Report Number1416980-2020-05996
Device Sequence Number1
Product Code LHI
Combination Product (y/n)Y
PMA/PMN Number
K900585
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberH938738
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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