ULTRASAFE PLUS X100L PR GREEN CCL AMG 47474302

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-02-21 for ULTRASAFE PLUS X100L PR GREEN CCL AMG 47474302 manufactured by Becton Dickinson.

MAUDE Entry Details

Report Number3001741852-2020-00020
MDR Report Key9739383
Report SourceCONSUMER,FOREIGN,OTHER
Date Received2020-02-21
Date of Report2020-02-06
Date of Event2020-02-04
Date Mfgr Received2020-02-05
Device Manufacturer Date2019-02-11
Date Added to Maude2020-02-21
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 G1BECTON DICKINSON
Manufacturer StreetFARADAY ROAD DORCAN
Manufacturer CitySWINDON WILTSHIRE SN3 5JH
Manufacturer CountryUK
Manufacturer Postal CodeSN3 5JH
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTRASAFE PLUS X100L PR GREEN CCL AMG
Generic NameULTRASAFE
Product CodeMEG
Date Received2020-02-21
Catalog Number47474302
Lot Number10498526
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON
Manufacturer AddressFARADAY ROAD DORCAN SWINDON WILTSHIRE SN3 5JH UK SN3 5JH


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-21

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