FDA.reportPublic FDA data

MAUDE MDR 2156005

MDR report key
2156005
Report number
1061932-2011-00649
Event key
0
Event type
3
Date of event
2010-01-29
Date received
2011-07-01
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
1DIFF AC-T PAK REAGENT 15LBECKMAN COULTER, INC.GGKNA8547134114145KN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-0101. R

Event Narratives#

D

Patient 1

AN OPERATOR REPORTED DILUENT WAS SPLASHED INTO HER EYES AS SHE WAS OPENING THE SEAL ON REAGENT #1 IN THE DIFF AC-T PAK REAGENT 15L. THE OPERATOR WAS WEARING SAFETY GLASSES, GLOVES AND LAB COAT. HOWEVER, HER SAFETY GLASSES WERE INSUFFICIENT TO PREVENT EXPOSURE. THE OPERATOR FLUSHED HER EYES WITH WATER FOR 15 MINS AND SOUGHT MEDICAL ATTENTION. THE OPERATOR STATED THAT SHE IS NOT INJURED. IT IS UNK IF INTERVENTION WAS REQUIRED WHEN THE OPERATOR SOUGHT MEDICAL ATTENTION.

N

Patient 1

REVIEW OF PRODUCT LABELING ON THE MATERIAL SAFETY DATA SHEET (MSDS) (B)(4), PROVIDES THE FOLLOWING INSTRUCTION: "IF PRODUCT ENTERS EYES, WASH EYES GENTLY UNDER RUNNING WATER FOR 15 MINS OR LONGER, MAKING SURE EYELIDS ARE HELD OPEN. IF PAIN OR IRRITATION OCCUR, OBTAIN MEDICAL ATTENTION." THE MSDS ALSO CONTAINS THE FOLLOWING FOR EYE PROTECTION: "SAFETY GLASSES OR CHEMICAL GOGGLES SHOULD BE WORN TO PREVENT EYE CONTACT." PRODUCT LABELING ANALYSIS DETERMINED LABELING IS SUFFICIENT. ROOT CAUSE FOR THIS EVENT WAS NOT DETERMINED. USER ERROR CONTRIBUTED TO THE EVENT AS EYE PROTECTION WAS INSUFFICIENT TO PREVENT SPLASHING FROM ENTERING EYE AREA. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.