Brand Name | ACCUCATH, 18GX1.25 BASIC |
Type of Device | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
BARD ACCESS SYSTEMS |
605 n. 5600 w. |
salt lake city UT 84116 |
|
Manufacturer (Section G) |
BARD REYNOSA S.A. DE C.V. -9617592 |
blvd. montebello #1 |
parque industrial colonial |
reynosa, tamaulipas |
MX
|
|
Manufacturer Contact |
kayla
olsen
|
605 n. 5600 w. |
salt lake city, UT 84116
|
8015225010
|
|
MDR Report Key | 9679565 |
MDR Text Key | 178108760 |
Report Number | 3006260740-2020-00415 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
UDI-Device Identifier | 00801741110900 |
UDI-Public | (01)00801741110900 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K153298 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/12/2019,02/06/2020 |
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 Expiration Date | 01/31/2020 |
Device Model Number | N/A |
Device Catalogue Number | AC0181250 |
Device Lot Number | RECZ1908 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 12/12/2019 |
Distributor Facility Aware Date | 12/06/2019 |
Event Location |
Hospital
|
Date Report to Manufacturer | 01/17/2020 |
Initial Date Manufacturer Received |
01/17/2020 |
Initial Date FDA Received | 02/06/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/01/2018 |
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;
|
Patient Age | 21 |
|
|