Brand Name | ARROW EPIDURAL CATHETERIZATION KIT |
Type of Device | ANESTHESIA CONDUCTION KIT |
Manufacturer (Section D) |
ARROW INTL., INC. |
reading PA 19605 |
|
Manufacturer (Section G) |
ARROW INTL., INC. |
312 commerce pl. |
|
|
|
Manufacturer Contact |
margie
burton, rn
|
po box 12600 |
durham, NC 27709
|
9194334965
|
|
MDR Report Key | 4094960 |
MDR Text Key | 4831814 |
Report Number | 1036844-2014-00360 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility,Company Representative |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
08/20/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/02/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Catalogue Number | ASK-05502-MGH |
Device Lot Number | 23F14B1149 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 08/20/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/01/2014 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |