FDA.reportPublic FDA data

MAUDE MDR 2339993

MDR report key
2339993
Report number
1061932-2011-02065
Event key
0
Event type
3
Date of event
2009-10-01
Date received
2011-11-04
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
MS. NORA ZEROUNIAN
Address
250 S KRAEMER BLVD BREA CA 92821 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COULTER S-CAL CALIBRATORBECKMAN COULTER, INC.KRYNA6245194717N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-040

Event Narratives#

D

Patient 1

THE CUSTOMER REPORTED AN S-CAL CALIBRATOR VIAL LEAKING WHILE MIXING AND THE S-CAL CAP CAME OFF THE CONTAINER. THE OPERATOR WAS WEARING GLOVES AND LABORATORY SCRUB CLOTHING. THE CALIBRATOR SPILLED ON THE FLOOR, THE COUNTER AND THE CABINET DOORS AND ON THE FRONT OF THE CUSTOMER'S SCRUBS AND PANT LEGS. THE CUSTOMER WENT HOME TO CHANGE CLOTHES THEN HAD HER BLOOD DRAWN FOR POTENTIAL BIOHAZARD EXPOSURE TESTING. THE CUSTOMER STATED THAT SHE RECEIVED THE CALIBRATOR FROM ANOTHER FACILITY. THE OTHER FACILITY USED ONE VIAL OF CALIBRATOR AND SENT THE REMAINING VIA TO HER. THE CUSTOMER DID NOT INITIALLY OBSERVE ANY LEAKS FROM THE CALIBRATOR. THERE WAS NO EXPOSURE OF POTENTIAL BIOHAZARD TO MUCOUS MEMBRANES OR TO OPEN LESIONS.

N

Patient 1

THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. PRODUCT WAS REPLACED AT THE TIME OF THE EVENT. BASED UPON AVAILABLE INFO THE ROOT CAUSE IS UNK.