FDA.reportPublic FDA data

MAUDE MDR 4364756

MDR report key
4364756
Report number
MW5039794
Event key
0
Event type
3
Date of event
2014-12-21
Date received
2014-12-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPINAL EPIDURAL KITSPINAL EPIDURAL KITARROW INTLOFT23F14H0737

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-12-220

Event Narratives#

D

Patient 1

DURING A COMBINED SPINAL/EPIDURAL PROCEDURE, UPON REMOVAL OF THE CATHETER, THE CATHETER SNAPPED AND BROKE OFF. A PORTION OF THE CATHETER IS IMBEDDED IN THE PATIENT. THE ANESTHESIOLOGIST LEFT A MESSAGE WITH THE MANUFACTURER REGARDING THIS MATTER.