PAXGENE? BLOOD CCFDNA TUBE 768165

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for PAXGENE? BLOOD CCFDNA TUBE 768165 manufactured by Becton, Dickinson And Company (bd).

Event Text Entries

[136616695] 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


[136616696] It was reported that 2 of the paxgene? Blood ccfdna tubes were found collapsed before use.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9617032-2019-00191
MDR Report Key8344046
Date Received2019-02-15
Date of Report2019-03-22
Date of Event2019-01-31
Date Mfgr Received2019-01-31
Device Manufacturer Date2018-06-07
Date Added to Maude2019-02-15
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 Sequence Number: 0

Brand NamePAXGENE? BLOOD CCFDNA TUBE
Generic NameBLOOD SPECIMEN COLLECTION DEVICE
Product CodePJE
Date Received2019-02-15
Catalog Number768165
Lot Number8158948
Device Expiration Date2019-07-31
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No0
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY (BD)
Manufacturer AddressBELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US

Device Sequence Number: 1

Brand NamePAXGENE? BLOOD CCFDNA TUBE
Generic NameBLOOD SPECIMEN COLLECTION DEVICE
Product CodeJKA
Date Received2019-02-15
Catalog Number768165
Lot Number8158948
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBECTON, DICKINSON AND COMPANY (BD)
Manufacturer AddressBELLIVER WAY BELLIVER INDUSTRIAL ESTATE PLYMOUTH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-15

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