Brand Name | HUDSON CO2 SAMPLING CANNULA A, 14FT 14FT, M |
Type of Device | ANALYZER, GAS, CARBON-DIOXIDE, |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
research triangle park NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
3015 carrington mill blvd |
|
morrisville NC 27560 |
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
9194334854
|
|
MDR Report Key | 6930204 |
MDR Text Key | 89945782 |
Report Number | 3011137372-2017-00303 |
Device Sequence Number | 1 |
Product Code |
CCK
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K143469 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/20/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/09/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 06/07/2022 |
Device Catalogue Number | 2848 |
Device Lot Number | 170524 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/28/2017 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 11/30/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|