MAUDE MDR 2161958

MDR report key
2161958
Report number
3002807968-2011-00008
Event key
0
Event type
3
Date of event
2011-03-08
Date received
2011-04-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
LASSE MOLLER, SPECIALIST
Address
AKANDEVEJ 21 BRONSHOJ 2700 DA
Phone
827-827-8273
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CLINITUBES D941G-80-140X5GLASS CAPPILLARY BLOOD SAMPLERRADIOMETER MEDICAL APS.GIOD941G-80-140X5942-882R0449R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-140

Event Narratives#

D

Patient 1

ON (B)(4), 2011, AT 9:15 AM IN THE EMERGENCY DEPARTMENT WITHIN THE ISOLATION ROOM, AN AUXILIARY NURSE WAS PLACING END CAPS ONTO THE CAPILLARY WHEN THE GLASS BROKE AND SOME OF THE SAMPLE WAS SPLASHED INTO THE NURSE'S EYE. THE SAMPLE WAS FOUND TO BE (B)(6).

N

Patient 1

USER WAS AN AUXILIARY NURSE PART OF THE "(B)(6)" FOR DRAWING BLOOD. THERE IS AN INCIDENT REPORT WITHIN THE "(B)(6)" OF THE HOSPITAL; THE PERSON RESPONSIBLE IN THIS DEPT IS (B)(6). THE REPORT WAS REQUESTED BUT WE HAVE BEEN TOLD THAT IT IS CONFIDENTIAL. THE TUBE HAS BEEN DISPOSED OF DUE TO IT BEING CONTAMINATED, AND THERE ARE NO PHOTOS OF THE BROKEN TUBE. THE PATIENT WAS BEING HELD IN AN ISOLATION ROOM AND NO WITNESSES WERE IN THE ROOM WHEN THE INCIDENT OCCURRED. NO INFORMATION IS AVAILABLE REGARDING IF THE USER WAS PROPERLY TRAINED. IT WILL TAKE MONTHS PRIOR TO KNOWING WHETHER THE NURSE HAS BEEN INFECTED. A FOLLOW UP REPORT WILL BE ISSUED IF THIS INFORMATION CAN BE OBTAINED.