Brand Name | JELCO SAFETY IV CATHETER |
Type of Device | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
SMITHS MEDICAL ASD, INC. |
201 west queen st. |
southington CT 06489 |
|
MDR Report Key | 9081161 |
MDR Text Key | 160148420 |
Report Number | 9081161 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Type of Report
| Initial,Followup |
Report Date |
08/28/2019 |
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 Catalogue Number | 3263 |
Device Lot Number | 3794723 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/28/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 09/18/2019 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/18/2019 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/18/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|