FDA.reportPublic FDA data

MAUDE MDR 6974476

MDR report key
6974476
Report number
9610691-2017-00008
Event key
0
Event type
3
Date of event
2017-09-22
Date received
2017-10-24
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
MR. SANJAY PARIKH
Address
6230 OLD DOBBIN LANE SUITE 250 COLUMBIA MD 21045 US
Phone
410-410-4107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMBU NEUROLINE INOJECT NEEDLEELECTRODE, NEEDLE, DIAGNOSTIC ELECTROMYOGRAPH - INOJECT NEEDLEAMBU A/SIKT74438-45/101957984Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-2401. R

Event Narratives#

N

Patient 1

ONLY HUB WAS RETURNED FOR INVESTIGATION. DENTED MARK WAS OBSERVED ON THE COMPLAINANT SAMPLE HUB. FROM THE SIMULATION TEST RESULT, THE BENDING ANGLE AROUND 40O AND 70O WILL CAUSE THE NEEDLE (CANNULA) TO BREAK OFF AFTER 45 TIMES AND 12 TIMES OF BENDING AT OPPOSITE DIRECTION RESPECTIVELY. SECOND SIMULATION TEST WAS PERFORMED BY PENETRATING THE NEEDLE TO THE HARD SURFACE (SIMULATION OF PENETRATION TO PATIENT WITH HARDER MUSCLE /IN CONTACT WITH BONE) TO SEE THE NEEDLE CONDITION DURING PENETRATION AND TO SEE WHERE THE NEEDLES BREAKS OFF. SIMULATION TEST DETERMINED THAT THE NEEDLE WOULD START TO BEND WHEN ENTERED INTO HARD SURFACE. THE BENDING POINT OF THE NEEDLE WAS SHIFTED FROM THE MIDDLE OF THE NEEDLE TO THE INTERSECTION BETWEEN THE HUB AND THE NEEDLE WHEN THE PENETRATION ANGLE WAS INCREASED. BASED ON THE SIMULATION TESTS, WE CAN CONCLUDE THAT THE BIGGER BENDING ANGLE COULD BREAK NEEDLE FROM THE HUB. THE CONDITION BECAME WORSE IF THE BENDING FULCRUM WAS AT THE INTERSECTION BETWEEN THE HUB AND THE NEEDLE ESPECIALLY WHEN THE PENETRATION WAS DONE ON THE HARDER SURFACE (MUSCLE) OR HIT THE BONE. IT IS SUSPECTED THAT THE NEEDLE WAS BENT AT WIDE ANGLE WHICH CAUSED THE NEEDLE TO BREAK FROM THE HUB. FOR THE LAST 12 MONTHS, COMPLAINT RATE IS AT 0 CPPM. THIS EVENT WAS CAUSED BY USE ERROR.

D

Patient 1

WHEN PATIENT WAS RECEIVING INJECTION AT RIGHT LATERAL HIP REGION, THE NEEDLE BROKE OFF AT THE HUB WHEN INJECTING. SURGERY WAS PERFORMED TO REMOVE THE NEEDLE BUT UNABLE TO RETRIEVE NEEDLE.