ULTRASAFE X100L PR CLEAR SSL NVS STEIN 47475102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,other report with the FDA on 2020-03-18 for ULTRASAFE X100L PR CLEAR SSL NVS STEIN 47475102 manufactured by Becton Dickinson.

MAUDE Entry Details

Report Number3001741852-2020-00023
MDR Report Key9850814
Report SourceDISTRIBUTOR,FOREIGN,OTHER
Date Received2020-03-18
Date of Report2020-03-10
Date of Event2019-12-19
Date Mfgr Received2020-03-10
Device Manufacturer Date2016-02-19
Date Added to Maude2020-03-18
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 X100L PR CLEAR SSL NVS STEIN
Generic NameULTRASAFE
Product CodeMEG
Date Received2020-03-18
Catalog Number47475102
Lot Number9165509
Device Expiration Date2020-01-22
OperatorLAY USER/PATIENT
Device AvailabilityN
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 2020-03-18

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