FDA.reportPublic FDA data

MAUDE MDR 2504651

MDR report key
2504651
Report number
2050012-2012-00823
Event key
0
Event type
3
Date of event
2012-03-02
Date received
2012-03-26
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. DUNG NGUYEN
Address
250 SOUTH KRAEMER BOULEVARD BREA CA 92821 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYNCHRON DRUG CALIBRATOR 2CALIBRATORS, DRUG SPECIFICBECKMAN COULTER, INC.DLJ469630M101710N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-03-260

Event Narratives#

D

Patient 1

ON (B)(6) 2012, CUSTOMER REPORTED THAT THEY RECEIVED A VIAL OF DRUG CALIBRATOR 2 THAT HAD LEAKED APPROXIMATELY 2 MLS IN THE BOX DURING TRANSIT. CUSTOMER STATED THAT THE LEAK WAS CAUSED BY A LOOSE CAP. NO INJURY OR EXPOSURE WAS REPORTED DUE TO THE LEAK. IT WAS DECIDED THAT AN MDR SHOULD BE FILED FOR THIS EVENT BECAUSE THE PRODUCT CONTAINS MATERIAL OF HUMAN ORIGIN, WHICH MAY BE POTENTIALLY INFECTIOUS, AND UPON RECUR COULD CAUSE SERIOUS INJURY.

N

Patient 1

BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS (B)(4).