Brand Name | PI PICC KIT: 2-L 5 FR X 50 CM |
Type of Device | PERIPHERALLY INSERTED CATHETER PRODU |
Manufacturer (Section D) |
ARROW INTERNATIONAL INC. |
reading PA |
|
Manufacturer (Section G) |
ARROW INTERNATIONAL INC. |
312 commerce place |
|
asheboro NC 27203 |
|
Manufacturer Contact |
jamie
hartz
|
2400 bernville road |
reading, PA 19605
|
|
MDR Report Key | 5813309 |
MDR Text Key | 50182414 |
Report Number | 1036844-2016-00432 |
Device Sequence Number | 1 |
Product Code |
LJS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K113277 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
07/14/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/21/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2017 |
Device Catalogue Number | CDC-35052-HPK1A |
Device Lot Number | 23F16D0570 |
Other Device ID Number | 00801902072603 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/14/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/19/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |