MAUDE MDR 9186135

MDR report key: 9186135
Report number: 9617032-2019-01163
Event key: 0
Event type: 3
Date of event: 2019-09-27
Date received: 2019-10-14
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 100
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: BDX BRETT WILKO
Address: 9450 SOUTH STATE STREET SANDY UT 84070 US
Phone: 801-801-8015
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	PAXGENE? BLOOD RNA TUBE	RNA PREANALYTICAL SYSTEMS	BECTON, DICKINSON AND COMPANY (BD)	NTW		762165	8081590				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-10-14	0	1. O

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
04053727000149	PAXgene® Blood RNA Kit	PreAnalytiX GmbH	NTW	2025-02-26
04053727621658	PAXgene® Blood RNA Tube	PreAnalytiX GmbH	NTW	2016-10-25
54053727621653	PAXgene® Blood RNA Tube	PreAnalytiX GmbH	NTW	2016-10-25

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K082150	NTW	MODIFICATION TO PAXGENE BLOOD RNA SYSTEM	Preanalytix GmbH	2009-02-04
510(k)	DEN050003	NTW	PAXGENE BLOOD RNA SYSTEM	Preanalytix GmbH	2005-04-18