Brand Name | ARROW |
Type of Device | MULTI-LUMEN CENTRAL VENOUS CATHETERIZATION |
Manufacturer (Section D) |
TELEFLEX (ARROW INTERNATIONAL) |
2400 bernville rd |
reading PA 19605 |
|
Manufacturer (Section G) |
TELEFLEX (ARROW INTERNATIONAL |
2400 bernville rd. |
|
reading PA 19605 |
|
Manufacturer Contact |
cheyenne
stewart
|
3000 east sawyer road |
republic, MO 65738
|
4177303937
|
|
MDR Report Key | 11205164 |
MDR Text Key | 244017180 |
Report Number | 3014527682-2021-00001 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 20801902117216 |
UDI-Public | 20801902117216 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
01/20/2021 |
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 |
Health Professional
|
Device Model Number | IPN036437 |
Device Catalogue Number | CDC-45703-XP1A |
Device Lot Number | 23F20C0330 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
01/12/2021 |
Initial Date FDA Received | 01/20/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |