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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION 2000 ML TPN BAG; SET, I.V. FLUID TRANSFER Back to Search Results
Catalog Number H938740
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 01/28/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an unspecified quantity of 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked coming from the 2 end seals on the ports.It was stated that the bag ¿was only sealed by the ports, the sides were not sealed at all¿.The leaks were discovered during setup and preparation.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d4 lot # and expiration date (upon follow up, customer clarified information), d9, h3, h4 and h6.H4: the lot was manufactured october 29, 2020 to october 31, 2020.H10: the device was received for evaluation.Unaided visual inspection observed an incomplete sealing defect at the lower right and left port sides of the bag located at the shoulder port weld.Functional testing was performed using tap water which observed a large leak from the unsealed bottom right and left sides of the ports at the shoulder port weld areas.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was due to a variation in the manufacturing equipment weld process.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
2000 ML TPN BAG
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11352579
MDR Text Key233032230
Report Number1416980-2021-00772
Device Sequence Number1
Product Code LHI
UDI-Device Identifier00085412477244
UDI-Public(01)00085412477244
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 03/23/2021
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 Other
Device Expiration Date09/30/2023
Device Catalogue NumberH938740
Device Lot Number60266057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Initial Date Manufacturer Received 01/28/2021
Initial Date FDA Received02/19/2021
Supplement Dates Manufacturer Received03/10/2021
Supplement Dates FDA Received03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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