ULTRASAFE X100L PNG CLEAR NVS STEIN 47439230

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-02-26 for ULTRASAFE X100L PNG CLEAR NVS STEIN 47439230 manufactured by Becton Dickinson Hungary Kft (bd).

MAUDE Entry Details

Report Number3009081593-2020-00021
MDR Report Key9753451
Report SourceDISTRIBUTOR,OTHER
Date Received2020-02-26
Date of Report2020-02-17
Date of Event2020-01-13
Date Mfgr Received2020-02-17
Device Manufacturer Date2019-02-28
Date Added to Maude2020-02-26
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 HUNGARY KFT (BD)
Manufacturer StreetUVEGGYAR UTCA 3
Manufacturer CityKORNYE TATABANYA 2851
Manufacturer CountryHU
Manufacturer Postal Code2851
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTRASAFE X100L PNG CLEAR NVS STEIN
Generic NamePISTON SYRINGE
Product CodeMEG
Date Received2020-02-26
Catalog Number47439230
Lot Number9059604
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON HUNGARY KFT (BD)
Manufacturer AddressUVEGGYAR UTCA 3 KORNYE TATABANYA 2851 HU 2851


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-26

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