CELSITE 4433750

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-24 for CELSITE 4433750 manufactured by B.braun Medical Sas France.

MAUDE Entry Details

Report Number9612452-2020-00012
MDR Report Key9872511
Report SourceFOREIGN,USER FACILITY
Date Received2020-03-24
Date of Report2020-03-24
Date of Event2020-02-03
Date Mfgr Received2020-02-27
Device Manufacturer Date2018-11-08
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS CATHERINE BOISMENU
Manufacturer Street30 AVENUE DES TEMPS MODERNES
Manufacturer CityCHASSENEUIL DU POITOU, 86360
Manufacturer CountryFR
Manufacturer Postal86360
Manufacturer G1B.BRAUN MEDICAL SAS FRANCE
Manufacturer Street30 AVENUE DES TEMPS MODERNES
Manufacturer CityCHASSENEUIL DU POITOU, 86360
Manufacturer CountryFR
Manufacturer Postal Code86360
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCELSITE
Generic NameACCESS PORT SYSTEM
Product CodeLJT
Date Received2020-03-24
Returned To Mfg2020-03-03
Model Number4433750
Lot Number36939309
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerB.BRAUN MEDICAL SAS FRANCE
Manufacturer Address30 AVENUE DES TEMPS MODERNES CHASSENEUIL DU POITOU, 86360 FR 86360


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-24

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