MAUDE MDR 2328395

MDR report key
2328395
Report number
1061932-2011-02088
Event key
0
Event type
3
Date of event
2011-10-11
Date received
2011-11-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. DUNG NGYUEN
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
1DXH 800 CELL LYSEPRODUCTS, RED-CELL LYSING PRODUCTSBECKMAN COULTER, INC.GGKNA6280191707001N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-080

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT A BOTTLE OF DXH CELL LYSE WAS FOUND TO BE LEAKING UPON ARRIVAL TO THE BECKMAN COULTER INC., (BEC) WAREHOUSE IN (B)(4). THE PACKAGE WAS DAMPED ON ARRIVAL AND WHILE ATTEMPTING TO REMOVE THE CONTAINER THE PACKAGE RIPPED CAUSING A FLUID SPILL. THE WAREHOUSE PERSONNEL STATED THAT THEY WERE WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GOGGLES AND LABORATORY COAT WHEN THE EVENT OCCURRED. NO INJURIES OCCURRED AND NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED AND THERE IS AN EXPOSURE/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THERE WAS NO REPORT OF DEATH OR INJURY IN CONNECTION TO THIS EVENT.

N

Patient 1

PER MSDS LABELING: SAFETY GLASSES OR CHEMICAL GOGGLES SHOULD BE WORN TO PREVENT EYE CONTACT. REFER (B)(4) OR APPROPRIATE GOVERNMENT STANDARDS AND IMPERVIOUS GLOVES, SUCH AS NITRILE OR EQUIVALENT, SHOULD BE WORN TO PREVENT SKIN CONTACT. REFER (B)(4) OR APPROPRIATE GOVERNMENT STANDARDS. NO ADDITIONAL INFORMATION IS AVAILABLE. THE ROOT CAUSE FOR THE LEAK IS UNKNOWN. (B)(4).