Brand Name | DELTEC |
Type of Device | PORT &; CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL MD, INC. |
6000 nathan lane north |
minneapolis MN 55442 |
|
MDR Report Key | 6892919 |
MDR Text Key | 87658726 |
Report Number | 6892919 |
Device Sequence Number | 1 |
Product Code |
LJT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/12/2017,09/15/2017 |
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 |
Physician
|
Device Model Number | 21-4071-24 |
Device Lot Number | 87X050 |
Other Device ID Number | TWO OF THE SAME TYPE OF DEVIC |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/12/2017 |
Event Location |
Hospital
|
Date Report to Manufacturer | 09/12/2017 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/26/2017 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|