FDA.reportPublic FDA data

MAUDE MDR 1145275

MDR report key
1145275
Report number
1056553-2008-00002
Event key
0
Event type
3
Date of event
2008-07-29
Date received
2008-09-02
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
LYNN KENNEDY, DIRECTOR
Address
6830 MEADOWRIDGE CT. ALPHARETTA GA 30005 US
Phone
770-770-7708
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NAC-1825MLLPROSTATE BIOPSY NEEDLEREMINGTON MEDICAL, INC.KNWNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-09-0201. O

Event Narratives#

D

Patient 1

USER FACILITY CONTACTED SALES DEPARTMENT ON 08/04/2008, AND STATED THAT TWO PATIENTS WHO UNDERWENT PROSTATE BIOPSIES AT, THEIR CENTER IN 2008, USING THE NEEDLES WERE LATER DIAGNOSED AT AN ER WITH INFECTION AND SEPSIS IN THEIR URINE AND BLOOD. THE BIOPSIES WERE PERFORMED BY TWO DIFFERENT DOCTORS IN TWO DIFFERENT ROOMS. PATIENT CULTURES CAME BACK POSITIVE FOR E. COLI INFECTIONS (DIFFERENT STRAINS). BOTH PATIENTS HAVE RECOVERED.

N

Patient 1

A REVIEW OF THE LOT HISTORY FOR THE NEEDLES INVOLVED IN THE EVENT WAS PERFORMED; ALL STERILIZATION PARAMETERS WERE MET PRIOR TO PRODUCT RELEASE. PRODUCT MET ALL SPECIFICATIONS AND NO NON-CONFORMANCES WERE ASSOCIATED WITH THE LOT. REMINGTON MEDICAL SENT SAMPLES FROM THE LOT FOR STERILITY TESTING AND THE RESULTS SHOWED THE TESTED SAMPLES WERE STERILE. ON 08/07/2008, THE USER FACILITY REPORTING THE EVENT, CONTACTED REMINGTON MEDICAL AND STATED THAT THEY RAN A CULTURE ON A REMINGTON NEEDLE THEY HAD FROM THE SAME LOT AS THE SUSPECTED NEEDLES AND THAT THE TESTED NEEDLE WAS NEGATIVE FOR GROWTH.