EVA BAG-500ML AZB8152

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-10-07 for EVA BAG-500ML AZB8152 manufactured by Baxter Healthcare - Sao Paulo.

Event Text Entries

[1474599] The customer reported to baxter (b)(4) of an eva bag that presented a leak. The condition occurred during filling. There was no patient injury or medical intervention necessary. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


[8767843] (b)(4). The sample is not available for evaluation, therefore, the condition cannot be confirmed or duplicated and the assignable root cause could not be determined. The batch review was completed for the reported lot and no deviations were found. This device is manufactured for distribution outside of the united states (us); therefore, it does not contain a us 510k number. However, this mdr is being submitted because it is the same as or similar to a product distributed within the us.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number6000001-2010-03802
MDR Report Key1859718
Report Source01,05
Date Received2010-10-07
Date of Report2010-09-08
Date of Event2010-08-31
Date Mfgr Received2010-09-08
Date Added to Maude2011-05-11
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 FDA0
Event Location0
Manufacturer ContactKAREN KIRBY
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone8472704541
Manufacturer G1BAXTER HEALTHCARE - SAO PAULO
Manufacturer StreetAV. ENGENHEIRO EUSEBIO STEVAUX
Manufacturer CitySAO PAULO
Manufacturer CountryBR
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEVA BAG-500ML
Generic NameBAG, RESERVOIR
Product CodeBTC
Date Received2010-10-07
Catalog NumberAZB8152
Lot NumberPE28N1
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - SAO PAULO
Manufacturer AddressAV. ENGENHEIRO EUSEBIO STEVAUX SAO PAULO BR


Patients

Patient NumberTreatmentOutcomeDate
10 2010-10-07

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