2000 ML TPN BAG H938740

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for 2000 ML TPN BAG H938740 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[185900501] Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[185900502] It was reported that a 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked. The leak was observed to be a "a pin hole near the side seam". This issue was identified after filling and prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-01882
MDR Report Key9907058
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-06
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone2242702068
Manufacturer G1AVAILMED
Manufacturer StreetC. INDUSTRIAL LT. 001 MZ. 105 NO 20905 INT A, COL CD IND.
Manufacturer CityTIJUANA, BAJA CALIFORNIA 22444
Manufacturer CountryMX
Manufacturer Postal Code22444
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name2000 ML TPN BAG
Generic NameSET, I.V. FLUID TRANSFER
Product CodeLHI
Date Received2020-03-31
Model NumberNA
Catalog NumberH938740
Lot Number60200414
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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