FDA.reportPublic FDA data

MAUDE MDR 7575406

MDR report key
7575406
Report number
2243072-2018-01054
Event key
0
Event type
3
Date of event
2016-11-07
Date received
2018-06-06
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
1BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBESPECIMEN TRANSPORT AND STORAGE CONTAINERBECTON DICKINSONKDWUNKNOWNUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-06-0601. O

Event Narratives#

N

Patient 1

THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE MANUFACTURER: UNKNOWN. BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. MANUFACTURING LOCATION: UNKNOWN. BD CORPORATE HEADQUARTERS IN (B)(4)HAS BEEN LISTED. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

D

Patient 1

IT WAS REPORTED THAT BD VACUTAINER? URINE ANALYSIS PRESERVATIVE TUBE HAD "ERRONEOUS RESULTS" NO REPORT OF INJURY OR MEDICAL INTERVENTION. NO REPORT OF BLOOD EXPOSURE TO MUCOUS MEMBRANE.