Brand Name | DOT,4FR POWERMIDLINE |
Type of Device | MIDLINE CATHETER |
Manufacturer (Section D) |
C.R. BARD, INC. (BASD) -3006260740 |
605 north 5600 west |
salt lake city 84116 |
|
Manufacturer (Section G) |
BARD REYNOSA S.A. DE C.V. -9617592 |
blvd. montebello #1 |
parque industrial colonial |
reynosa, tamaulipas 88780 |
MX
88780
|
|
Manufacturer Contact |
kelsey
erickson
|
605 north 5600 west |
salt lake city 84116
|
8015950700
|
|
MDR Report Key | 12957776 |
MDR Text Key | 281903218 |
Report Number | 3006260740-2021-05160 |
Device Sequence Number | 1 |
Product Code |
PND
|
UDI-Device Identifier | 00801741108761 |
UDI-Public | (01)00801741108761 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153393 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
11/30/2021 |
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 | N/A |
Device Catalogue Number | P4154108D |
Device Lot Number | REFU3874 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/23/2021 |
Initial Date FDA Received | 12/07/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/01/2021 |
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;
|