BD FILTER NEEDLE 305200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-01-08 for BD FILTER NEEDLE 305200 manufactured by Bd Medical (bd West) Medical Surgical.

MAUDE Entry Details

Report Number1911916-2019-01378
MDR Report Key9564756
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-01-08
Date of Report2020-01-22
Date of Event2019-12-19
Date Mfgr Received2019-12-24
Device Manufacturer Date2016-07-22
Date Added to Maude2020-01-08
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 ContactBDX BRETT WILKO
Manufacturer Street9450 SOUTH STATE STREET
Manufacturer CitySANDY UT 84070
Manufacturer CountryUS
Manufacturer Postal84070
Manufacturer Phone8015652341
Manufacturer G1BD MEDICAL (BD WEST) MEDICAL SURGICAL
Manufacturer Street1852 10TH AVENUE
Manufacturer CityCOLUMBUS NE 68601
Manufacturer CountryUS
Manufacturer Postal Code68601
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBD FILTER NEEDLE
Generic NameMANUAL SURGICAL INSTRUMENT FOR GENERAL USE
Product CodeGAA
Date Received2020-01-08
Model Number305200
Catalog Number305200
Lot Number6166729
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBD MEDICAL (BD WEST) MEDICAL SURGICAL
Manufacturer Address1852 10TH AVENUE COLUMBUS NE 68601 US 68601


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-01-08

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