FDA.reportPublic FDA data

MAUDE MDR 8085923

MDR report key
8085923
Report number
1213809-2018-00800
Event key
0
Event type
3
Date of event
2018-11-02
Date received
2018-11-19
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
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BD LUER TIP CAP, STERILE TRAYLIQUID MEDICATION DISPENSERBECTON DICKINSON MEDICAL SYSTEMSKYW3058225201798Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-11-1901. O

Event Narratives#

N

Patient 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

D

Patient 1

IT WAS REPORTED WITH THE USE OF THE BD LUER TIP CAP, STERILE TRAY THERE WAS AN ISSUE WITH FOREIGN MATTER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.