EFFLUENT BAG 107650

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-21 for EFFLUENT BAG 107650 manufactured by Baxter Healthcare - Medolla Modena Blood.

Event Text Entries

[139439827] The event occurred on an unspecified date, reported as "recently". Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[139439828] It was reported that during treatment with a sp-418 effluent bag, an external fluid leak was observed. The location of the leak was unknown. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9610270-2019-00001
MDR Report Key8439751
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-03-21
Date of Report2019-04-23
Date Mfgr Received2019-04-23
Date Added to Maude2019-03-21
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 - MEDOLLA MODENA BLOOD
Manufacturer StreetVIA MODENESE, 66
Manufacturer CityMEDOLLA MODENA 41036
Manufacturer CountryIT
Manufacturer Postal Code41036
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEFFLUENT BAG
Generic NameSYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES
Product CodeMON
Date Received2019-03-21
Model NumberNA
Catalog Number107650
Lot Number18216
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAXTER HEALTHCARE - MEDOLLA MODENA BLOOD
Manufacturer AddressMEDOLLA MODENA


Patients

Patient NumberTreatmentOutcomeDate
10 2019-03-21

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