Brand Name | STATLOCK IV ULTRA NEO CATHETER RETAINER, ULTRA NEONATE PADS 25 BOX |
Type of Device | STAND, INFUSION |
Manufacturer (Section D) |
C.R. BARD, INC. (BASD) -3006260740 |
605 north 5600 west |
salt lake city 84116 |
|
Manufacturer (Section G) |
DAVOL SURGICAL INNOVATIONS -9616067 |
ave. roberto fierro #6408 |
parque industrial aeropuerto |
cd. juarez, chih s.a. de c.v. 32690 |
MX
32690
|
|
Manufacturer Contact |
kelsey
erickson
|
605 north 5600 west |
salt lake city 84116
|
8015950700
|
|
MDR Report Key | 11939373 |
MDR Text Key | 254378344 |
Report Number | 3006260740-2021-02188 |
Device Sequence Number | 1 |
Product Code |
FOX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,other |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/04/2021 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | IV0501 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/05/2021 |
Initial Date FDA Received | 06/04/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
|
|