N
Patient 1
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
MAUDE MDR 9866150
- MDR report key
- 9866150
- Report number
- 1036844-2020-00094
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-09-30
- Date received
- 2020-03-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- EFFIE JEFFERSON
- Address
- 3015 CARRINGTON MILL BLVD MORRISVILLE 27560 US
- Phone
- 919-919-9194
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EPIDURAL CATHETERIZATION KIT | ANESTHESIA CONDUCTION CATHETER | ARROW INTERNATIONAL INC. | BSO | AK-05502 | 23F19F0158 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-23 | 0 | 1. R |
Event Narratives#
D
Patient 1
RECEIVED VIA MEDWATCH FROM FDA# (B)(4). THE COMPLAINT STATES THAT AN EPIDURAL CATHETER WAS PLACED BY ANESTHESIA. INSERTION WAS UNCOMPLICATED. TWELVE HOURS LATER, NURSE ENCOUNTERED DIFFICULTY UPON ATTEMPT AT CATHETER REMOVAL. ANESTHESIA CALLED FOR ASSISTANCE. UPON CATHETER REMOVAL; TIP WAS NOT INTACT. MISSING APPROXIMATELY 5CM OF CATHETER TIP. PATIENT REQUIRED SURGICAL EXPLORATION FOR CATHETER TIP REMOVAL FOUR DAYS LATER.