D
Patient 1
THE CUSTOMER ALLEGES THE CIRCUIT WAS OBSERVED TO BE CRACKED PRIOR TO USE ON PATIENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
MAUDE MDR 4552866
- MDR report key
- 4552866
- Report number
- 3004365956-2015-00064
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-01-29
- Date received
- 2015-02-25
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- WARRENDA PETERSON
- 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 | SINGLE HEATED DUAL LIMB W DRAIN | BREATHING CIRCUIT | TELEFLEX MEDICAL | CAG | 880-34KIT | 74G1401890 | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-02-25 | 0 |
Event Narratives#
N
Patient 1
(B)(4). DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE REPORTED LOT# AND THERE WERE NO ISSUES RELATED TO FUNCTIONAL ISSUES NEITHER ON THE PRODUCT OR COMPONENTS DURING THE MANUFACTURING OF THE MATERIAL. THE REPORTED COMPLAINT CANNOT BE CONFIRMED AT THIS TIME BECAUSE THE DEFECTIVE SAMPLE IS CURRENTLY BEING INVESTIGATED. THE REPORTED DEFECT IS A KNOWN ISSUE AND IS CURRENTLY BEING INVESTIGATED BY THE MANUFACTURER TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAILURE. WHEN ADDITIONAL INFORMATION IS PROVIDED A FOLLOW-UP REPORT WILL BE SUBMITTED.