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 2018-05-11 for PAXGENE? BLOOD RNA TUBE 762165 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[108146807] Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited. Retention samples were selected from bd inventory for evaluation, and the customer's indicated failure mode for (b)(6) was not observed as all samples met specifications. A review of the manufacturing records was completed for the incident lot and no issues were identified.
Patient Sequence No: 1, Text Type: N, H10


[108146808] It was reported while using the paxgene? Blood rna tube that there were concerns about the integrity of the rna.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2018-01074
MDR Report Key7508559
Date Received2018-05-11
Date of Report2018-04-30
Date of Event2017-09-21
Date Mfgr Received2017-09-21
Device Manufacturer Date2016-07-12
Date Added to Maude2018-05-11
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 ContactBDX BRETT WILKO
Manufacturer Street9450 SOUTH STATE STREET
Manufacturer CitySANDY UT 84070
Manufacturer CountryUS
Manufacturer Postal84070
Manufacturer Phone8015652845
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 Received2018-05-11
Catalog Number762165
Lot Number6194599
Device Expiration Date2018-03-31
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY (BD)
Manufacturer AddressBELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-11

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