FDA.reportPublic FDA data

MAUDE MDR 367141

MDR report key
367141
Report number
1039284-2001-00001
Event key
0
Event type
3
Date of event
2001-11-12
Date received
2001-12-18
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
TOM CLEMENT
Address
100 RODOLPHE ST. DURHAM NC 27712 US
Phone
919-919-9196
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BACT/ALERT CULTURE BOTTLEMICROBIAL GROWTH MONITERBIOMERIEUX, INC.JSCNANAUNKNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12001-12-1801. R

Event Narratives#

D

Patient 1

CO RECEIVED A REPORT 2001 THAT A LAB TECHNICIAN CUT THEIR FINGER ON A BROKEN BACT/ALERT BLOOD CULTURE BOTTLE. CO CONTACTED THE SITE DECEMBER 2001 TO COLLECT ADDITIONAL DETAILS, AND WERE INFORMED THE TECHNICIAN CUT THEIR FINGER WHILE REMOVING THE GLASS BOTTLE FROM THE BACT INSTRUMENT. BLOOD AND MEDIA FROM THE BOTTLE SPLASHED INTO THEIR FACE. THE TECHNICIAN WAS GIVEN BASIC FIRST AID FOR THE CUT AND STARTED ON ANTIRETROVIRAL DRUGS WHILE AWAITING SEROLOGICAL TESTING ON THE PATIENT WHO'S BLOOD WAS IN THE BOTTLE.