SYRINGE PLASTIPAK 20ML LL S/SU 990687

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 2020-03-19 for SYRINGE PLASTIPAK 20ML LL S/SU 990687 manufactured by Becton Dickinson Ind. Cirurgicas Ltda.

MAUDE Entry Details

Report Number3003916417-2020-00091
MDR Report Key9856528
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-19
Date of Report2020-03-31
Date of Event2020-02-28
Date Mfgr Received2020-02-28
Device Manufacturer Date2019-08-23
Date Added to Maude2020-03-19
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 IND. CIRURGICAS LTDA
Manufacturer Street550 RUA CYRO CORREIA PEREIRA
Manufacturer CityCURITIBA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYRINGE PLASTIPAK 20ML LL S/SU
Generic NameSYRINGE
Product CodeFMF
Date Received2020-03-19
Catalog Number990687
Lot Number9235062
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON IND. CIRURGICAS LTDA
Manufacturer Address550 RUA CYRO CORREIA PEREIRA CURITIBA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-19

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