Brand Name | ARROW |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
TELEFLEX INCORPORATED |
11245 n distribution cove |
olive branch MS 38654 |
|
MDR Report Key | 7330171 |
MDR Text Key | 102079733 |
Report Number | 7330171 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 10801902117202 |
UDI-Public | (01)10801902117202 |
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 |
03/06/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 03/31/2019 |
Device Model Number | IPN036474 |
Device Catalogue Number | CDC-45703-PB1A |
Device Lot Number | 13F17L0099 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/06/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/06/2018 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 03/12/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Treatment | NO OTHER DEVICES USED, OPENED FROM NEW PACK |
|
|