SEE H.10 364902

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-23 for SEE H.10 364902 manufactured by Bd Caribe Ltd..

MAUDE Entry Details

Report Number2618282-2020-00026
MDR Report Key9866287
Report SourceOTHER,USER FACILITY
Date Received2020-03-23
Date of Report2020-03-27
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-23
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 G1BD CARIBE LTD.
Manufacturer StreetROAD 31 K.M. 24.3
Manufacturer CityJUNCOS
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSEE H.10
Generic NameBLOOD SPECIMEN COLLECTION DEVICE
Product CodeJKA
Date Received2020-03-23
Model Number364902
Catalog Number364902
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBD CARIBE LTD.
Manufacturer AddressROAD 31 K.M. 24.3 JUNCOS US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-23

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