Brand Name | 5.0FR URETHANE UMB CATH |
Type of Device | CATHETER, UMBILICAL ARTERY |
Manufacturer (Section D) |
COVIDIEN |
edificio b20 calle #2 zona fra |
alajuela |
CS |
|
Manufacturer (Section G) |
COVIDIEN |
edificio b20 calle #2 zona fra |
|
alajuela |
CS
|
|
Manufacturer Contact |
jill
saraiva
|
15 hampshire street |
mansfield, MA 02048
|
5086183640
|
|
MDR Report Key | 8890358 |
MDR Text Key | 163306385 |
Report Number | 3009211636-2019-00665 |
Device Sequence Number | 1 |
Product Code |
FOS
|
UDI-Device Identifier | 20884527005120 |
UDI-Public | 20884527005120 |
Combination Product (y/n) | N |
Reporter Country Code | SF |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/13/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Model Number | 8888160341 |
Device Catalogue Number | 8888160341 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
07/15/2019 |
Initial Date FDA Received | 08/13/2019 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|