FDA.reportPublic FDA data

MAUDE MDR 4999153

MDR report key
4999153
Report number
1036844-2015-00321
Event key
0
Event type
3
Date of event
2015-07-16
Date received
2015-08-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MARGIE BURTON, RN
Address
3015 CARRINGTON MILL BLVD. MORRISVILLE NC 27560 US
Phone
919-919-9194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARROW CONTINUOUS PERIPHERAL NERVE BLOCK KIT; 2ANESTHESIA CONDUCTION KITARROW INTL., INC.OGJASK-20608-ROPR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-110

Event Narratives#

N

Patient 1

(B)(4). A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON A LOT NUMBER FROM SALES HISTORY. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE CATHETER AND NEEDLE WITH NO RELEVANT FINDINGS. THE IFU FOR THIS PRODUCT WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU FOR THIS PRODUCT STATES "USE EXTREME CARE TO NEVER ADJUST POSITION OF THE NEEDLE WHILE CATHETER TIP IS STILL ADVANCED BEYOND TIP OF NEEDLE." IF THE CATHETER IS RETRACTED AGAINST THE NEEDLE BEVEL, IT CAN LEAD THE CATHETER TO SHEAR AS THE CUSTOMER REPORTED. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE POTENTIAL CAUSE OF DIFFICULTY THREADING THE CATHETER COULD NOT BE DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT THE SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE POTENTIAL CAUSE OF DIFFICULTY THREADING THE CATHETER THROUGH THE NEEDLE COULD NOT BE DETERMINED BASED UPON THE INFO PROVIDED AND WITHOUT A SAMPLE.

D

Patient 1

A CUSTOMER ALLEGES HAVING DIFFICULTY IN REMOVING THE NEEDLE AND STYLET. THE CATHETER SHEARED AND HAD TO BE RESTARTED. NO PT INJURY REPORTED. PROCEDURE - TOTAL KNEE REPLACEMENT.