FDA.reportPublic FDA data

MAUDE MDR 111566

MDR report key
111566
Report number
MW1011851
Event key
0
Event type
3
Date of event
1997-07-26
Date received
1997-08-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FAN AEROBIC CULTURE BOTTLESBLOOD CULTURE BOTTLEORGANON TEKNIKA CORP.JSCFAN AEROBIC BOTTLE55948203899NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11997-08-0701. O

Event Narratives#

D

Patient 1

BLOOD WAS DRAWN FROM THIS PT AND PLACED IN A FAN BLOOD CULTURE BOTTLE. WHEN THE BOTTLE WAS RECEIVED IN THE LAB, THE BOTTOM WAS NOTED TO BE YELLOW INDICATING A POSITIVE BOTTLE. LESS THAN 1 HR. HAD ELAPSED FROM THE TIME OF COLLECTION TO THE TIME OF RECEIPT IN THE LAB. RPTR CONCLUDED THAT THE BOTTLE MUST HAVE BEEN CONTAMINATED PRIOR TO INOCULATION. THIS APPEARS TO BE A DEFECTIVE PRODUCT FROM THE MFR.