FDA.reportPublic FDA data

MAUDE MDR 5012245

MDR report key
5012245
Report number
8040412-2015-00175
Event key
0
Event type
3
Date of event
2015-07-18
Date received
2015-08-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
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 5CCTELEFLEX MEDICALFGH17130516014FE26R R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-180

Event Narratives#

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.

D

Patient 1

ALLEGED EVENT: THE PATIENT LOST THE CATHETER WHILE BEING TRANSFERRED TO THE TOILET. THERE WERE NO CLINICAL CONSEQUENCES AS A RESULT OF THE INCIDENT. THE CATHETER HAD BEEN IN PLACE FOR NINE DAYS PRIOR TO THE INCIDENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

N

Patient 1

(B)(4). ADDITIONAL METHOD: DEVICE HISTORY RECORD FOR LOT (14FE26) WAS REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. ONE ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION. BASED ON OBSERVATION THE BALLOON OF THE SAMPLE WAS SPLIT. A SIMULATION TEST WAS CONDUCTED WITH REPRESENTATIVE SAMPLES FROM PRODUCTION ON THE SAME CATHETER SIZE AND BALLOON VOLUME. NO DEFLATION ISSUE WAS OBSERVED. BALLOONS ARE STILL INFLATED TO ITS NORMAL CONDITION AND SHAPE. IN OUR CURRENT STANDARD OPERATING PROCEDURE, THE PRODUCTS ARE SUBJECTED TO 100% VISUAL INSPECTION, AND LEAK TEST. ANY DEFECTIVE RAW BALLOON WILL BE CULLED OUT BEFORE BEING SENT TO THE NEXT PROCESS. BASED ON THE INVESTIGATION CONDUCTED, WE COULD NOT LINK ANY PROCESS DISCREPANCY THAT COULD LEAD TO THE BALLOON SPLIT ISSUE. THEREFORE, WE COULD NOT CONFIRM THE COMPLAINT, AS STATED.

D

Patient 1

ALLEGED EVENT: THE PATIENT LOST THE CATHETER WHILE BEING TRANSFERRED TO THE TOILET. THERE WERE NO CLINICAL CONSEQUENCES AS A RESULT OF THE INCIDENT. THE CATHETER HAD BEEN IN PLACE FOR NINE DAYS PRIOR TO THE INCIDENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.