Brand Name | CARAVEL |
Type of Device | CATHETER |
Manufacturer (Section D) |
ASAHI INTECC CO., LTD. |
3-100 akatsuki-cho |
seto, aichi 489-0 071 |
JA 489-0071 |
|
MDR Report Key | 9758978 |
MDR Text Key | 181578476 |
Report Number | 3004718255-2020-00134 |
Device Sequence Number | 1 |
Product Code |
DQY
|
UDI-Device Identifier | 04547327108782 |
UDI-Public | (01)04547327108782(17)220930(10)191003K37A |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/26/2020,02/14/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/30/2022 |
Device Model Number | CRV150-19P |
Device Catalogue Number | CRV150-19P |
Device Lot Number | 191003K37A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 02/24/2020 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/26/2020 |
Distributor Facility Aware Date | 02/14/2020 |
Device Age | 3 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/26/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/26/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|