Brand Name | UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH |
Type of Device | INTRODUCER, 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 |
kayla
olsen
|
605 north 5600 west |
salt lake city 84116
|
8015950700
|
|
MDR Report Key | 15070050 |
MDR Text Key | 300243798 |
Report Number | 3006260740-2022-02825 |
Device Sequence Number | 1 |
Product Code |
DYB
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K915167 |
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 |
07/19/2022 |
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 | 0668945 |
Device Lot Number | REFX4607 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/04/2022 |
Initial Date FDA Received | 07/20/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/01/2021 |
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;
|