BIOFLO DIALYSIS CATHETER H965103028041

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-09 for BIOFLO DIALYSIS CATHETER H965103028041 manufactured by Angiodynamics.

MAUDE Entry Details

Report Number1317056-2020-00055
MDR Report Key9805811
Report SourceDISTRIBUTOR,FOREIGN
Date Received2020-03-09
Date of Report2020-03-26
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Date Added to Maude2020-03-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAW RYAN
Manufacturer Street10 GLENS FALLS TECHNICAL PARK
Manufacturer CityGLENS FALLS, NY
Manufacturer CountryUS
Manufacturer Phone7424488
Manufacturer G1ANGIODYNAMICS
Manufacturer Street10 GLENS FALLS TECHNICAL PARK
Manufacturer CityGLENS FALLS, NY
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIOFLO DIALYSIS CATHETER
Generic NameCATHETER, HEMODIALYSIS, IMPLANTED
Product CodeMSD
Date Received2020-03-09
Returned To Mfg2020-03-23
Catalog NumberH965103028041
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerANGIODYNAMICS
Manufacturer Address10 GLENS FALLS TECHNICAL PARK GLENS FALLS, NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-09

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