N
Patient 1
(B)(4). THE DEVICE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
MAUDE MDR 6256177
- MDR report key
- 6256177
- Report number
- 8040412-2017-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-12-18
- Date received
- 2017-01-17
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SUPRAFLEX SUPRAPUBIC 12F | TELEFLEX MEDICAL | KOB | 170703120 | UNKNOWN | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-01-17 | 0 |
Event Narratives#
D
Patient 1
THE DEVICE WAS INSERTED INTO THE PATIENT 40 DAYS BEFORE OF THE INCIDENT. THE DEVICE CAME OUT OF THE PATIENT AND THE BALLOON HAD DEFLATED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
N
Patient 1
QN#(B)(4). THE DEVICE LOT NUMBER WAS NOT PROVIDED; THEREFORE A DHR REVIEW COULD NOT BE CONDUCTED. ONE ACTUAL SAMPLE WAS RETURNED FOR INVESTIGATION. BASED ON THE COMPLAINT DESCRIPTION, IT WAS REPORTED THAT THE BALLOON WAS SLIPPED OUT FROM THE PATIENT AND FOUND THAT THE BALLOON WAS DEFLATED. INVESTIGATION WAS CONDUCTED BY INFLATING THE SAMPLE RETURNED WITH 10ML OF RED COLOR WATER AND LEFT ON THE WORK BENCH FOR A PERIOD OF 20 MINUTES. THE BALLOON STAYED INFLATED TO ITS NORMAL CONDITION AND SHAPE. NO DEFLATION ISSUE OR LEAK BALLOON WAS OBSERVED ALONG THE CATHETER. ALSO, THE SAMPLE CAN BE INFLATED AND DEFLATED SUCCESSFULLY WITH NO ISSUE. BALLOON DEFLATION COULD HAPPEN DUE TO VARIOUS REASONS SUCH AS LEAKAGE AT THE BALLOON, SHAFT OR FUNNEL AREAS. VALVE MALFUNCTION ALSO COULD CONTRIBUTE TO THIS BALLOON DEFLATION ISSUE. IN CURRENT STANDARD OPERATING PROCEDURE, THE BALLOONS ARE SUBJECTED TO 100% VISUAL INSPECTION AND ANY DEFECTIVE RAW BALLOON NOTICED WILL BE CULLED OUT BEFORE PROCEED TO THE NEXT PROCESS. UPON COMPLETION OF ASSEMBLY PROCESS, THE CATHETER WILL BE THEN SUBJECTED TO 100% BALLOON INSPECTION AND 20 MINUTES LEAK TEST. ANY CATHETER WITH DEFECTIVE BALLOON WILL BE CULLED OUT DURING THIS PROCESS. OTHER REMARKS: BASED ON THE INVESTIGATION CONDUCTED, NO LEAK BALLOON FOUND ON THE RETURNED SAMPLE. THE BALLOON CAN BE INFLATED AND DEFLATED WITH NO ISSUE. THEREFORE, THIS COMPLAINT COULD NOT BE CONFIRMED.
D
Patient 1
THE DEVICE WAS INSERTED INTO THE PATIENT 40 DAYS BEFORE OF THE INCIDENT. THE DEVICE CAME OUT OF THE PATIENT AND THE BALLOON HAD DEFLATED. THE PATIENT'S CONDITION WAS REPORTED AS FINE.