FDA.reportPublic FDA data

MAUDE MDR 1625403

MDR report key
1625403
Report number
1018233-2010-00018
Event key
0
Event type
3
Date of event
2009-12-17
Date received
2010-03-05
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
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
1BARDIA FOLEY CATHETERC.R. BARD, INC.KODNA123516AMYRJR031R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-03-050

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE CATHETER BALLOON BURST LEAVING FRAGMENTS IN THE PATIENT'S UTERUS. CATHETER WAS PLACED IN A PATIENT'S UTERUS ON (B) (6) 2009 DURING A MYOMA RECESSION PROCEDURE TO PREVENT BLEEDING. THE CATHETER FELL OUT OF THE PATIENT THE FOLLOWING DAY. THE PATIENT DID NOT NOTIFY THE HOSPITAL UNTIL (B) (6) 2010 THAT SHE HAD EXPELLED FRAGMENTS OF THE CATHETER BALLOON DURING MENSTRUATION. NO ADDITIONAL EVENT INFO COULD BE OBTAINED.

N

Patient 1

THE ACTUAL USED SAMPLE WAS NOT RETURNED FOR EVALUATION, HOWEVER, AN UNUSED SAMPLE FROM THE SAME LOT WAS PROVIDED. VISUAL INSPECTION OF THE SAMPLE DID NOT FIND ANY CONDITIONS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CATHETER WAS FUNCTIONALLY TESTED BY INFLATING AND DEFLATING THE BALLOON WITH NO ISSUES NOTED. THE CATHETER BALLOON WAS INFLATED AND IMMERSION TESTING WAS PERFORMED WITH NO RUPTURING OF THE BALLOON BEING OBSERVED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR THE LOT NUMBER PROVIDED. THERE WERE NO NON-CONFORMANCES NOTED IN THE DHR THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT LABELING INDICATES THAT THE CATHETER IS FOR UROLOGICAL USE ONLY. THE INVESTIGATION CONCLUDED THAT THE PRODUCT WAS BEING USED OUTSIDE ITS LABELING INDICATIONS AND THE REPORTED EVENT IS NOT RELATED TO ANY DEFICIENCIES IN THE MANUFACTURING OF THE CATHETER. (B) (4).