Brand Name | GROSHONG 4 FR PICC BASIC TRAY |
Type of Device | 150611071-LONG TERM INTRAVASCULAR CATHETER |
Baseline Brand Name | SPECIAL 4 FR PICC |
Baseline Generic Name | LONG TERM INTRAVASCULAR CATHETER |
Baseline Catalogue Number | 6715405 |
Baseline Model Number | 6715405 |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
3600-C.R. BARD ACCESS SYSTEMS PRODUCTS |
5425 west amelia earhart dr. |
salt lake city UT 84166 |
|
Manufacturer (Section D) |
3600-C.R. BARD ACCESS SYSTEMS PRODUCTS |
5425 west amelia earhart dr. |
salt lake city UT 84166 |
|
Manufacturer (Section G) |
BARD ACCESS SYSTEMS |
5425 w amelia earhart drive |
|
salt lake city UT 84116 |
|
Manufacturer Contact |
stephanie
erskine, dir
|
5425 w amelia earhart dr. |
salt lake city
, UT 84116 |
(801)
595
-0700
|
|
Device Event Key | 274023 |
MDR Report Key | 283173 |
Event Key | 265613 |
Report Number | 1720496-2000-00331 |
Device Sequence Number | 1 |
Product Code | DQO |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/11/2000 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 06/19/2000 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device EXPIRATION Date | 03/01/2004 |
Device MODEL Number | 6715405 |
Device Catalogue Number | 6715405 |
Device LOT Number | 36FJ0160 |
OTHER Device ID Number | BAS-0199 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 05/30/2000 |
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 04/26/2000 |
Device Age | no info |
Event Location |
Unknown
|
Date Report TO Manufacturer | 05/11/2000 |
Date Manufacturer Received | 05/11/2000 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 06/01/1999 |
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
No
|
Is this an Explanted Device? |
|
Type of Device Usage |
Unkown
|