PAXGENE? BLOOD RNA TUBE 762165

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for PAXGENE? BLOOD RNA TUBE 762165 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[137558000] (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[137558001] It was reported that before use of the paxgene? Blood rna tube there was hair like foreign matter in the tube.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2019-00241
MDR Report Key8375263
Date Received2019-02-27
Date of Report2019-04-23
Date of Event2019-02-06
Date Mfgr Received2019-02-07
Device Manufacturer Date2018-03-22
Date Added to Maude2019-02-27
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 AND COMPANY (BD)
Manufacturer StreetBELLIVER WAY BELLIVER INDUSTRIAL ESTATE
Manufacturer CityPLYMOUTH
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePAXGENE? BLOOD RNA TUBE
Generic NameRNA PREANALYTICAL SYSTEMS
Product CodeNTW
Date Received2019-02-27
Returned To Mfg2019-02-20
Catalog Number762165
Lot Number8081580
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY (BD)
Manufacturer AddressBELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-27

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