INTRAVIA CONTAINER EMPTY 2B8011

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 2020-02-07 for INTRAVIA CONTAINER EMPTY 2B8011 manufactured by Baxter Healthcare Corporation.

Event Text Entries

[178223055] Four (4) devices were received for evaluation. The containers were inspected in a lighted inspection booth via the tyndall illumination to aid in the observation of visible particulates. The particulate was verified; however, the cause of the condition 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.
Patient Sequence No: 1, Text Type: N, H10


[178223056] During product evaluation, four (4) intravia containers were observed to have particulate inside the fluid pathway. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1416980-2020-00491
MDR Report Key9683620
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-07
Date of Report2020-02-07
Date Mfgr Received2020-01-09
Device Manufacturer Date2019-07-10
Date Added to Maude2020-02-07
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 G1BAXTER HEALTHCARE - DOMINICAN REPUBLIC
Manufacturer StreetCARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA
Manufacturer CityHAINA, SAN CRISTOBAL
Manufacturer CountryDR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTRAVIA CONTAINER EMPTY
Generic NameCONTAINER, I.V
Product CodeKPE
Date Received2020-02-07
Model NumberNA
Catalog Number2B8011
Lot NumberDR19G09062
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE CORPORATION
Manufacturer AddressDEERFIELD IL


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-07

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