FDA.reportPublic FDA data

MAUDE MDR 6370137

MDR report key
6370137
Report number
1423395-2017-00005
Event key
0
Event type
3
Date received
2017-03-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. MEGAN DEBUS
Address
THREE LAKES DRIVE NORTHFIELD IL 60093 US
Phone
847-847-8477
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NEEDLE IN CSMC MINOR LAP PACKNIPOR MEDICALFDEDYNJ0665347I16JK2210Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-0101. R

Event Narratives#

N

Patient 1

IT WAS REPORTED A NEEDLE BROKE OFF DURING A PROCEDURE AND REMAINED IN THE PATIENT. THE SURGEON WAS INJECTING A SUBCUTANEOUS ANESTHETIC FOR A HERNIA REPAIR. DURING THE INJECTION THE NEEDLE "SNAPPED OFF" RIGHT ABOVE THE HUB. THE AMOUNT OF PRESSURE BEING APPLIED DURING THE INJECTION IS NOT KNOWN. THE PATIENT REQUIRED A CT SCAN AND A SECONDARY SURGERY TO REMOVE THE NEEDLE. NO FURTHER INFORMATION WAS MADE AVAILABLE. SAMPLE WAS RETURNED AND ISSUE CONFIRMED. A ROOT CAUSE CANNOT BE DETERMINED. NIPRO MEDICAL IS THE MANUFACTURER OF THE NEEDLE. THEY HAVE BEEN NOTIFIED, WILL CONDUCT AN INVESTIGATION AND MAKE THE DETERMINATION WHETHER ANY CORRECTIVE ACTION IS INDICATED. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION THIS MEDWATCH IS BEING FILED.

D

Patient 1

IT WAS REPORTED A NEEDLE BROKE DURING A PROCEDURE.