FDA.reportPublic FDA data

MAUDE MDR 8004554

MDR report key
8004554
Report number
9610691-2018-00006
Event key
0
Event type
3
Date of event
2018-09-27
Date received
2018-10-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
501
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR SANJAY PARIKH
Address
6230 OLD DOBBIN LANE SUITE 250 COLUMBIA MD 21048 US
Phone
410-410-4107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COCENTRIC NEEDLESELECTRODE NEEDLE DIAGNOSTICAMBU A/SIKT74025-30/251970438N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-2501. R

Event Narratives#

N

Patient 1

THE USED NEEDLE WAS DISCARDED. A BOX OF NEEDLES FROM THE SAME LOT WAS RETURNED FOR INVESTIGATION PURPOSES, AND A PHOTO AND A X-RAY IMAGE OF THE FAULT WERE RECEIVED. VISUAL INSPECTION OF THE RECEIVED IMAGES COULD VERIFY THE REPORTED FAILURE, AS THE NEEDLE WAS FOUND TO BE BROKEN, AND THE NEEDLE TIP WAS SHOWN ON THE X-RAY, INSIDE THE PATIENT. BASED ON THE INVESTIGATION IT IS HIGHLY SUSPECTED THAT THE CAUSE OF THE NEEDLE BREAK ARE DUE TO EXCESSIVE FORCE DURING INSERTION IN COMBINATION WITH MULTIPLE WIDE ANGLE BENDING. IS IT SUSPECTED THAT THE HANDLING OF THE NEEDLE UNDER SUCH CONDITIONS HAS WEAKENED THE NEEDLE STRENGTH, LEADING TO THE FAILURE. INVESTIGATIONS WERE CARRIED OUT, TO SIMULATE THE ROUGH BENDING OF THE NEEDLE. THE TESTED NEEDLES BEHAVED WITHIN SPECIFICATIONS. DURING NORMAL USAGE, THERE IS NO DANGER THAT THE NEEDLE WILL BREAK BECAUSE THEY ARE DESIGNED TO WITHSTAND MANY TIMES OF BENDING WITHIN THE FLEXIBLE LIMIT. THE REPORTED PROBLEM IS INCLUDED IN THE PRODUCT RISK ANALYSIS. THE RISK FOR A HAZARDOUS SITUATION TO OCCUR AS A RESULT OF THE REPORTED PROBLEM IS CONCLUDED TO BE ACCEPTABLE LOW. THE CURRENT REPORT DOES NOT RESULT IN A CHANGE OF THE RISK ASSESSMENT. THE OBSERVED COMPLAINT RATING IS WITHIN THE PROBABILITY LEVEL IDENTIFIED IN THE PRODUCT RISK.

D

Patient 1

THE NEEDLE WAS USED ON THE LEFT THIGH OF A FEMALE PATIENT. DURING THE PROCEDURE, THE NEEDLE TIP BROKE OF AND REMAINED IN THE PATIENT. THE PATIENT HAD TO GO THROUGH X-RAY SCREENING AND SURGERY TO REMOVE THE NEEDLE.