|
Model Number 0603140 PRODUCT CODE |
Device Problems
Disconnect;
Migration
|
Event Date 07/17/1998 |
Patient Outcome
Required Intervention;
|
Event Description
|
Right groin port-a-cath placement 3/4/98.
X-ray on 7/12/98 indicates "radiopaque wire over right heart/superior mediastinum.
" on 7/17/98 successful removal of right atrial free catheter which had dislodged from rt groin port-a-cath with the use of a snare.
|
|
Search Alerts/Recalls
|
|
|
Brand Name | BARDPORT |
Type of Device | VASCULAR ACCESS |
Baseline Device 510(K) Number | |
Baseline Device PMA Number | |
Manufacturer (Section F) |
BARD |
5425 west amelia earheart |
salt lake city UT 84116 |
|
Manufacturer (Section D) |
BARD |
5425 west amelia earheart |
salt lake city UT 84116 |
|
Device Event Key | 187959 |
MDR Report Key | 193438 |
Event Key | 181843 |
Report Number | 193438 |
Device Sequence Number | 1 |
Product Code | LJT |
Report Source |
User Facility
|
Reporter Occupation |
RISK MANAGER
|
Type of Report
| Initial |
Report Date |
10/20/1998 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 10/22/1998 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device MODEL Number | 0603140 PRODUCT CODE |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 10/20/1998 |
Distributor Facility Aware Date | 07/17/1998 |
Event Location |
Hospital
|
Date Report TO Manufacturer | 10/20/1998 |
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Patient TREATMENT DATA |
Date Received: 10/22/1998 Patient Sequence Number: 1 |
# | Treatment | Treatment Date |
1 |
CATHETER REMOVED 7/17/98. |
07/17/1998 |
|
|
|
Database last updated on January 30, 2009
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