Brand Name | PORT ACCESS NEEDLE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BARD ACCESS SYSTEMS, INC. |
605 north 5600 west |
salt lake city UT 84116 |
|
MDR Report Key | 16435151 |
MDR Text Key | 310177579 |
Report Number | 16435151 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00801741066207 |
UDI-Public | (01)00801741066207 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
01/30/2023 |
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 | LH-0031 |
Device Catalogue Number | LH-0031 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/30/2023 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/24/2023 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 02/24/2023 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|