BD KIESTRA? INOQULA+? TLA 447213

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-15 for BD KIESTRA? INOQULA+? TLA 447213 manufactured by Bd Kiestra Lab Automation.

MAUDE Entry Details

Report Number3010141591-2019-00170
MDR Report Key8899621
Date Received2019-08-15
Date of Report2019-08-02
Date of Event2019-07-18
Date Mfgr Received2019-07-18
Device Manufacturer Date2018-08-11
Date Added to Maude2019-08-15
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 KIESTRA LAB AUTOMATION
Manufacturer Street6 MARCONILAAN
Manufacturer CityDRACHTEN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Removal Correction Number1119779-07/23/2019-004-C
Event Type3
Type of Report0

Device Details

Brand NameBD KIESTRA? INOQULA+? TLA
Generic NameMICROBIAL SPECIMEN INOCULATION/STREAKING INSTRUMENT
Product CodeJTC
Date Received2019-08-15
Catalog Number447213
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBD KIESTRA LAB AUTOMATION
Manufacturer Address6 MARCONILAAN DRACHTEN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-15

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