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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 Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a 1000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from the additive port.The leak was discovered during mixing prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d9, h3, h4 and h6.H10: the device was received for evaluation.Visual inspection was performed which observed a tear/hole in the back side of the bag.A functional testing was performed which revealed a leak in the affected area.The leak from the additive port was not verified.The cause of the tear/hole could not be determined.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.
 
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Brand Name
1000 ML TPN BAG
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11339905
MDR Text Key232414793
Report Number1416980-2021-00709
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412477237
UDI-Public(01)00085412477237
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,foreig
Type of Report Initial,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2023
Device Catalogue NumberH938739
Device Lot Number60232901
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2021
Initial Date Manufacturer Received 01/26/2021
Initial Date FDA Received02/17/2021
Supplement Dates Manufacturer Received03/09/2021
Supplement Dates FDA Received03/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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