FDA.reportPublic FDA data

MAUDE MDR 4912588

MDR report key
4912588
Report number
8040412-2015-00147
Event key
0
Event type
3
Date of event
2015-06-01
Date received
2015-07-14
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
JASMINE BROWN
Address
3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US
Phone
919-919-9193
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1100% SIL TIEMANN 2WAY 5CCFOLEY CATHETERTELEFLEX MEDICALFGH17130514013GE31R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-07-140

Event Narratives#

D

Patient 1

ALLEGED EVENT: THE BALLOON BURST AND THE CATHETER WAS FOUND IN THE PATIENT'S BED WITH NO BALLOON SO THE BALLOON BURST INSIDE THE PATIENT'S BLADDER. HOWEVER THE NURSE CONFIRMED THAT THE PATIENT EVACUATED THE BALLOON PIECES THROUGH NATURAL MEANS. STERILE WATER 10 CC WAS USED TO INFLATE THE BALLOON. A LARGER SIZE CATHETER, SIZE 16, WAS INSERTED IN THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

N

Patient 1

(B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

N

Patient 1

(B)(4). THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. THERE WAS NO COMPLAINT DEVICE RETURNED FOR INVESTIGATION. THEREFORE , NO PHYSICAL ASSESSMENT COULD BE CONDUCTED. BURST BALLOON COULD BE DUE TO VARIOUS REASONS. HOWEVER, IN THE ABSENCE OF RETURNED SAMPLE AND LIMITED INFORMATION AVAILABLE ON THIS COMPLAINT, FURTHER INVESTIGATION COULD NOT BE CONDUCTED AND; THEREFORE COMPLAINT IS NOT CONFIRMED.

D

Patient 1

ALLEGED EVENT: THE BALLOON BURST AND THE CATHETER WAS FOUND IN THE PATIENT'S BED WITH NO BALLOON SO THE BALLOON BURST INSIDE THE PATIENT'S BLADDER. HOWEVER THE NURSE CONFIRMED THAT THE PATIENT EVACUATED THE BALLOON PIECES THROUGH NATURAL MEANS. STERILE WATER 10 CC WAS USED TO INFLATE THE BALLOON. A LARGER SIZE CATHETER, SIZE 16, WAS INSERTED IN THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.