FDA.reportPublic FDA data

MAUDE MDR 8479843

MDR report key
8479843
Report number
1424643-2019-00533
Event key
0
Event type
3
Date of event
2019-03-26
Date received
2019-04-03
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
JILL SARAIVA
Address
15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone
508-508-5084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
12 GA N/S COLL CONT YELLOW 20CONTAINER, SHARPSCOVIDIENMMK8970Y8970Y18H08463R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-030

Event Narratives#

N

Patient 1

THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

D

Patient 1

THE CUSTOMER REPORTED WHEN THE NURSE MOVED THE SHARPS CONTAINER WITH THE SHARPS INSIDE, SHE NOTICED THE BOTTOM OF THE SHARPS CONTAINER WAS CRACKED.