FDA.reportPublic FDA data

MAUDE MDR 1065518

MDR report key
1065518
Report number
3002769706-2008-00002
Event key
0
Event type
3
Date of event
2008-05-27
Date received
2008-06-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ELISABETH FRITZ
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 MP CULTURE BOTTLESMICROBIAL GROWTH MONITORBIOMERIEUX, INC.JTA2597971018685NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-06-250

Event Narratives#

D

Patient 1

A PLASTIC BACT/ALERT MP CULTURE BOTTLE WAS FOUND BROKEN IN THE BACT/ALERT INCUBATOR. AFB STAIN INDICATED THAT ITS CONTENTS WERE NEGATIVE. THERE WERE NO ADVERSE EVENTS NOTED AS A RESULT OF THIS INCIDENT. THE LAB WAS CLOSED AND A FORMALDEHYDE GAS STERILIZATION WAS PERFORMED.

N

Patient 1

THE USER HAD DISINFECTED THE PLASTIC BACT/ALERT MP CULTURE BOTTLE WITH BIOCLEANSE (TEKNOM), A DISINFECTANT, WHICH ACCORDING TO TEKNON'S APPLICATION CHART, IS NOT RECOMMENDED FOR THE USE ON POLYCARBONATE BOTTLES. BIOMERIEUX, INC. HAS INVESTIGATED THE INTERACTION OF SOME DISINFECTANTS ON ITS POLYCARBONATE BOTTLES AND HAS ISSUED A NOTICE ALERTING USERS TO READ THE DISINFECTANT'S LABEL TO DETERMINE COMPATIBILITY WITH POLYCARBONATE BOTTLES. BIOMERIEUX HAS ALSO MODIFIED ITS PACKAGE INSERT WITH A CAUTION ABOUT POLYCARBONATES AND CHOICE OF DISINFECTANTS BY THE USER.