FDA.reportPublic FDA data

MAUDE MDR 6619206

MDR report key
6619206
Report number
3005581270-2017-00005
Event key
0
Event type
3
Date of event
2017-04-20
Date received
2017-06-07
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
MS. MIA DUDICOVA
Address
IDA BUSINESS PARK GORT, CO.GALWAY H91PD EI
Phone
53-53-53 9
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DANTEC CONCENTRIC NEEDLE ELECTRODECONCENTRIC NEEDLE ELECTRODENATUS MANUFACTURING LIMITEDIKT9013S00129013S001241C/16/DN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-06-0701. O

Event Narratives#

N

Patient 1

APPLICABLE WORK ORDER WAS REVIEWED. IN PROCESS TESTING AND INSPECTIONS WERE REVIEWED - HUB ID, HUB TO COVER, HUB TO CANNULA. ALL SAMPLES TAKEN FOR THESE TESTS GAVE ACCEPTABLE RESULTS. NO NON-CONFORMANCES, REWORKS RELATED TO THIS LOT. ALL CHECKS WERE COMPLETED AS REQUIRED BY THE PROCESS AND QUALITY PLAN FOR THE DANTEC NEEDLE. CUSTOMER HAS BEEN CONTACTED VIA EMAIL WITH QUESTIONNAIRE TO PROVIDE THE REST OF THE REQUIRED INFORMATION BELOW . THE FOLLOWING INFORMATION HAVE NOT BEEN PROVIDED AND HAVE BEEN NOTED BY THE CUSTOMER NOT RELEVANT SINCE THERE WAS NO INTERACTION WITH PATIENT: PATIENT IDENTIFIER - NOT APPLICABLE, AGE AT THE TIME OF EVENT, DATE OF BIRTH - NOT APPLICABLE, SEX - NOT APPLICABLE, WEIGHT - NOT APPLICABLE, RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES - NOT APPLICABLE, OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS (E.G., ALLERGIES, RACE, PREGNANCY, SMOKING AND ALCOHOL USE, HEPATIC/RENAL DYSFUNCTION, ETC.) - NOT APPLICABLE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) - NOT APPLICABLE. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE SERIAL #, IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE, IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE, REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT, IF IND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND, ADVERSE EVENT TERM(S) - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES, IF REMEDIAL ACTION INITIATED, CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I(F), LIST CORRECTION/REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21 USC 360I(F). NOT RETURNED TO MANUFACTURER.

D

Patient 1

ISSUE WITH THE HUB OF THE 9013S0012: WHEN CUSTOMER TRIED TO REMOVE THE NEEDLE, THE NEEDLE AND METAL HUB CAME AWAY FROM THE COLOURED PLASTIC COVER BUT NOT THE NEEDLE. NO PATIENT IMPACT AS THE ATTEMPT TO DISCONNECT NEEDLE FROM THE CABLE HAPPENED AFTER THE TESTING HAS BEEN COMPLETED.