Brand Name | SMALLBORE EXTENSION SET |
Manufacturer (Section D) |
CAREFUSION CORPORATION |
san diego CA |
|
Manufacturer Contact |
michelle
bitto
|
10020 pacific mesa blvd |
san diego, CA 92121
|
8586173316
|
|
MDR Report Key | 3851356 |
MDR Text Key | 4656747 |
Report Number | 9616066-2014-00254 |
Device Sequence Number | 1 |
Product Code |
FPB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K960280 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Not Applicable
|
Remedial Action |
Other |
Type of Report
| Initial |
Report Date |
02/27/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/26/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/01/2016 |
Device Model Number | 20043E |
Device Catalogue Number | 20043E |
Device Lot Number | 13066691 |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 03/07/2014 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 02/27/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 07/01/2013 |
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 |
Treatment | THERAPY DATE UNK; LIFESHIELD PRIMARY SET: 12662/28, LOT UNK; ANGIOCATH CATHETER: 382533, LOT UNK; HOSPIRA CLAVE: 11956, LOT UNK, THERAPY DATE UNK |
|
|