SURECAN SAFETY II 4447012-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-07-24 for SURECAN SAFETY II 4447012-02 manufactured by B. Braun Medical France.

MAUDE Entry Details

Report Number9612452-2019-00085
MDR Report Key8821592
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-07-24
Date of Report2019-07-24
Date Mfgr Received2019-06-26
Device Manufacturer Date2017-10-24
Date Added to Maude2019-07-24
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 ContactMR. JONATHAN SEVERINO
Manufacturer Street861 MARCON BLVD.
Manufacturer CityALLENTOWN PA 18109
Manufacturer CountryUS
Manufacturer Postal18109
Manufacturer Phone4842408332
Manufacturer G1B. BRAUN MEDICAL FRANCE
Manufacturer Street30 AVENUE DES TEMPS MODERNES
Manufacturer City86360
Manufacturer CountryFR
Manufacturer Postal Code86360
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURECAN SAFETY II
Generic NameSET, ADMINISTRATION, INTRA
Product CodePTI
Date Received2019-07-24
Model Number4447012-02
Catalog Number4447012-02
Lot Number17L24G8661
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL FRANCE
Manufacturer Address30 AVENUE DES TEMPS MODERNES 86360 FR 86360


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-07-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.