Brand Name | ET TUBE, SHER-I-BRONCH, LS, 35 FR |
Type of Device | TUBE, TRACHEAL/BRONCHIAL, DIFF |
Manufacturer (Section D) |
TELEFLEX MEDICAL |
morrisville NC |
|
Manufacturer (Section G) |
TELEFLEX MEDICAL |
rancho el descanso |
|
tecate 21478 |
MX
21478
|
|
Manufacturer Contact |
katharine
tarpley
|
3015 carrington mill blvd |
morrisville, NC 27560
|
|
MDR Report Key | 17744314 |
MDR Text Key | 323385487 |
Report Number | 3003898360-2023-01344 |
Device Sequence Number | 1 |
Product Code |
CBI
|
UDI-Device Identifier | 04026704397600 |
UDI-Public | 04026704397600 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K180253 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/04/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/14/2023 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 5-16035 |
Device Lot Number | 73D2200124 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 10/17/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/07/2022 |
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 |
|
|