FDA.reportPublic FDA data

MAUDE MDR 1657652

MDR report key
1657652
Report number
1018233-2010-00030
Event key
0
Event type
3
Date of event
2010-03-09
Date received
2010-04-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NYCOLE SAYER
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
1BARD BRACHYSTAR SEED IMPLANT NEEDLEC.R. BARD, INC.IWJNA818205RETH0167R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-04-080

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT WHEN THE NEEDLE WAS REMOVED FROM THE PT, THE NEEDLE WAS CRACKED ABOUT 1/3 OF THE WAY UP. THE NEEDLE DID NOT BREAK OFF IN THE PT, IT WAS INTACT UPON REMOVAL WITH THE EXCEPTION OF THE CRACK. THE DR WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER DIFFICULTIES.

N

Patient 1

A REVIEW OF THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER FOUND NOTHING THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. AN ANALYSIS OF THE LABELING FOUND THE FOLLOWING: CAUTION - NEEDLES ARE NOT INTENDED TO PENETRATE BONE. IF RESISTANCE IS ENCOUNTERED, VERIFY NEEDLE POSITION. DO NOT PUSH INTO BONE; THIS MAY CAUSE NEEDLE TO BEND OR BREAK. REPLACE NEEDLE IF CANNULA, OR POINT, IS DAMAGED. (B)(4).