Brand Name | LIFTLOC SAFETY INFUSION SET 19G X 1 IN WITH Y-SITE |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
BARD ACCESS SYSTEMS |
605 n. 5600 w. |
salt lake city UT 84116 |
|
Manufacturer (Section G) |
BARD ACCESS SYSTEMS |
605 n. 5600 w. |
|
salt lake city UT 84116 |
|
Manufacturer Contact |
kayla
olsen
|
605 n. 5600 w. |
salt lake city, UT 84116
|
8015225010
|
|
MDR Report Key | 8371567 |
MDR Text Key | 137242678 |
Report Number | 3006260740-2019-00379 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 00801741047800 |
UDI-Public | (01)00801741047800 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K013394 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
02/26/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 0661910 |
Device Lot Number | ASCQS0076 |
Was Device Available for Evaluation? |
No
|
Event Location |
Hospital
|
Initial Date Manufacturer Received |
02/05/2019 |
Initial Date FDA Received | 02/26/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/01/2018 |
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 |
Patient Outcome(s) |
Required Intervention;
|