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 2019-04-02 for PAXGENE? BLOOD RNA TUBE 762165 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[140936031] Date of event: unknown. Medical device expiration date: unknown. (b)(6). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10


[140936032] It was reported that paxgene? Blood rna tube was missing additive. No serious injury or medical intervention was reported. The following information was provided by the initial reporter: material no. 762165 batch no. Unknown it was reported there were possible problems with the rna tube. She has questions regarding the processing of the tube and possible problems. She needs assistance with troubleshooting.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2019-00384
MDR Report Key8476056
Date Received2019-04-02
Date of Report2019-05-02
Date of Event2019-03-13
Date Mfgr Received2019-03-13
Date Added to Maude2019-04-02
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 Received2019-04-02
Catalog Number762165
Lot NumberUNKNOWN
Device Availability*
Device AgeDA
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 2019-04-02

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