FDA.reportPublic FDA data

MAUDE MDR 5672330

MDR report key
5672330
Report number
1018233-2016-00669
Event key
0
Event type
3
Date received
2016-05-23
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
JANNA PARKS
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MAXCORE DISPOSABLE BIOPSY GUNBIOPSY GUNBARD REYNOSA S.A. DE C.V. -9617592KNWMC1820UNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-230

Event Narratives#

N

Patient 1

NO SAMPLE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTION FOR USE STATES THE FOLLOWING: "TENERGIZE (COCK) INSTRUMENT BY PULLING BACK ON THE TOP SLIDE TO WITHDRAW THE CANNULA AND LOCK IN PLACE. THEN PULL BACK ON THE BOTTOM SLIDE TO WITHDRAW THE STYLET AND LOCK IN PLACE. REMOVE PROTECTIVE NEEDLE SHEATH AND YELLOW GUARD. INSTRUMENT IS READY TO FIRE WHEN BOTH SLIDES ARE LOCKED BACK. WHILE MAINTAINING INSTRUMENT'S POSITION AND THE NEEDLE ORIENTATION, DEPRESS THE REAR ACTUATOR BUTTON, OR PUSH THE SIDE ACTUATOR FORWARD (DIRECTION OF ARROW), TO CAUSE BOTH STYLET AND CANNULA TO AUTOMATICALLY ADVANCE." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

D

Patient 1

IT WAS REPORTED THAT THE BIOPSY GUN RAPIDLY FIRED WHILE BEING USED. NO PATIENT INJURY WAS REPORTED. THE SECOND TRIGGER WOULD NOT COCK AND THE GUN FIRED MULTIPLE TIMES.