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 2020-03-24 for 2000 ML TPN BAG H938740 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[184639648] The device was received and is currently awaiting evaluation completion. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[184639649] It was reported that an unspecified quantity of 2000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bags leaked "into the triangle in the corner of the bag during compounding. " there was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[188472118] Additional information was added: correction: the actual device was not returned to the manufacturer. The lot was manufactured from october 16, 2019 - october 17, 2019. The actual device was not available; however, two (2) companion samples were received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. Functional testing was performed with tap water on both samples and no leaks were observed on either device. The reported condition was not verified. 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1416980-2020-01662
MDR Report Key9871375
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-27
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-24
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 Received2020-03-24
Returned To Mfg2020-03-02
Model NumberNA
Catalog NumberH938740
Lot Number60210019
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.