FDA.reportPublic FDA data

MAUDE MDR 7567222

MDR report key
7567222
Report number
9617032-2018-02125
Event key
0
Event type
3
Date of event
2017-10-24
Date received
2018-06-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PAXGENE? BLOOD DNA TUBEBLOOD SPECIMEN COLLECTION DEVICEBECTON, DICKINSON AND COMPANY (BD)PJE7611657080759R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-0401. O

Event Narratives#

N

Patient 1

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 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.

D

Patient 1

IT WAS REPORTED THAT PAXGENE? BLOOD DNA TUBE UNDER FILLED. NO SERIOUS INJURY OR MEDICAL INTERVENTION.