D
Patient 1
ALLEGED EVENT: THE CATHETER WAS INSERTED PREOPERATIVELY AND WAS LATER FOUND SEVERED OR BROKEN AT THE Y JUNCTION. THE PATIENT'S CONDITION WAS REPORTED AS FINE.
MAUDE MDR 4913107
- MDR report key
- 4913107
- Report number
- 8040412-2015-00158
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-05-13
- Date received
- 2015-07-14
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
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 | 100%SILICONE 2WAY PED 3 CC | FOLEY CATHETER | TELEFLEX MEDICAL | FGH | 170003100 | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-14 | 0 |
Event Narratives#
N
Patient 1
(B)(4). THE DEVICE SAMPLE HAS NOT BEEN RETURNED 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 LOT NUMBER WAS NOT PROVIDED; THEREFORE A DHR REVIEW COULD NOT BE CONDUCTED. VISUAL EXAMINATION WAS CONDUCTED ON THE RETURNED SAMPLE AND IT WAS OBSERVED THAT THE CATHETER WAS BROKEN INTO TWO PARTS; ONE ON SHAFT AND THE FUNNEL. THE RETURNED SAMPLE WAS REALIGNED AND MEASURED ON THE LENGTH OF IT USING A CALIBRATED RULER. IT WAS OBSERVED THAT THE OVERALL LENGTH MET THE SPECIFICATION OF THIS PRODUCT. THEN, BOTH THE CATHETER SHAFT AND FUNNEL WERE EXAMINED USING THE DINO-LITE TO ANALYZE THE DAMAGED AREA. BASED ON THE OBSERVATION THE TORN EDGES WERE JAGGED WHERE MORE MATERIAL WAS SEEN ON ONE SIDE OF THE CATHETER. VISUAL EXAMINATION ON THE OTHER AREAS OF THE CATHETER SHAFT DID NOT REVEAL ANY SIGN OF ABRASION MARK OR SCRATCH. THERE IS NO TRACE OF NICK OR SCRATCHES ON THE EMBEDDED SHAFT. BASED ON THE INVESTIGATION CONDUCTED, THE CATHETER WAS FOUND TO BE BROKEN. NO OTHER RELATED ISSUE WITHIN THE MANUFACTURING PROCESSES THAT COULD LEAD TO DEFECTIVE PRODUCT. THEREFORE THIS COMPLAINT COULD NOT BE CONFIRMED.
D
Patient 1
ALLEGED EVENT: THE CATHETER WAS INSERTED PREOPERATIVELY AND WAS LATER FOUND SEVERED OR BROKEN AT THE Y JUNCTION. THE PATIENT'S CONDITION WAS REPORTED AS FINE.