FDA.reportPublic FDA data

MAUDE MDR 9834024

MDR report key
9834024
Report number
1213809-2020-00189
Event key
0
Event type
3
Date of event
2020-02-23
Date received
2020-03-16
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
1SYRINGE INTEGRA 3ML W/NDL 25X1 RBPISTON SYRINGEBECTON DICKINSON MEDICAL SYSTEMSMEG3052703052706299513R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-1601. O

Event Narratives#

N

Patient 1

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

D

Patient 1

IT WAS REPORTED THAT A SYRINGE INTEGRA 3ML W/NDL 25X1 RB WAS MISSING A CAP AND STUCK THE CUSTOMER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THE CUSTOMER WAS STUCK WITH A NEEDLE THAT DID NOT HAVE A CAP ON IT WHEN IT WAS RECEIVED. VERBATIM: CUSTOMER WAS STUCK WITH A NEEDLE THAT DIDN'T HAVE A CAP ON IT. IT WAS SHIPPED WITHOUT THE CAP. CUSTOMER IS SAYING THAT SHE WENT TO THE ER AND THEY ADVISED THAT SHE BE PLACED ON HIV MEDICATION AS A PREVENTATIVE BUT SHE IS HESITANT BECAUSE SHE IS PREGNANT. THE ER DID BLOOD WORK AND WILL MONITOR HER BUT SHE WAS WONDERING IF BD WOULD PAY FOR HER MEDICAL BILLS."