FDA.reportPublic FDA data

MAUDE MDR 6249497

MDR report key
6249497
Report number
1917413-2017-00007
Event key
0
Event type
3
Date of event
2016-08-10
Date received
2017-01-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
BDX BRETT WILKO
Address
9450 SOUTH STATE STREET SANDY UT 84070 US
Phone
801-801-8015
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUPCOLLECTION CUPBECTON, DICKINSON & CO.JXA364975UNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-01-1301. R

Event Narratives#

N

Patient 1

RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER?S INDICATED FAILURE MODE. (B)(4).

D

Patient 1

IT WAS REPORTED THAT A HEALTHCARE WORKER IN A PATIENT'S HOSPITAL ROOM STUCK HIMSELF/HERSELF WITH A CONTAMINATED LID OF A USED 120 ML BD VACUTAINER? PLASTIC URINE COLLECTION CUP WHILE DISPOSING OF IT IN A SHARPS CONTAINER. THE FACILITY CONSIDERED THIS TO BE A BLOOD BORNE PATHOGEN EXPOSURE. THE EMPLOYEE WAS SEEN BY EMPLOYEE HEALTH, RECEIVED POST EXPOSURE LAB WORK, AND (B)(6) SERIES IMMUNIZATIONS.