BD VACUTAINER? NO ADDITIVE (Z) PLUS TUBES 366408

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-21 for BD VACUTAINER? NO ADDITIVE (Z) PLUS TUBES 366408 manufactured by Becton, Dickinson & Co., (bd).

MAUDE Entry Details

Report Number1024879-2019-01492
MDR Report Key8918837
Date Received2019-08-21
Date of Report2019-09-04
Date of Event2019-08-05
Date Mfgr Received2019-08-05
Device Manufacturer Date2019-03-15
Date Added to Maude2019-08-21
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 & CO., (BD)
Manufacturer Street1575 AIRPORT ROAD
Manufacturer CitySUMTER SC 29153
Manufacturer CountryUS
Manufacturer Postal Code29153
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBD VACUTAINER? NO ADDITIVE (Z) PLUS TUBES
Generic NameSPECIMEN TRANSPORT AND STORAGE CONTAINER
Product CodeFMH
Date Received2019-08-21
Returned To Mfg2019-08-13
Catalog Number366408
Lot Number9074915
Device Expiration Date2019-03-15
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON & CO., (BD)
Manufacturer Address1575 AIRPORT ROAD SUMTER SC 29153 US 29153


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-08-21

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