Brand Name | BARD POWERMIDLINE CATHETER 3F, SINGLE-LUMEN |
Type of Device | MIDLINE CATHETER |
Manufacturer (Section D) |
C.R. BARD, INC. (BASD) -3006260740 |
605 north 5600 west |
salt lake city 84116 |
|
MDR Report Key | 12577185 |
MDR Text Key | 274759077 |
Report Number | 3006260740-2021-04130 |
Device Sequence Number | 1 |
Product Code |
PND
|
UDI-Device Identifier | 00801741162763 |
UDI-Public | (01)00801741162763 |
Combination Product (y/n) | N |
PMA/PMN Number | K153393 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Type of Report
| Initial |
Report Date |
09/27/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/05/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | CK000860 |
Device Lot Number | REFR0288 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 09/15/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/01/2021 |
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) |
Other;
|
|
|