Brand Name | FLEXTIP PLUS EPIDURAL CATHETER |
Type of Device | ANESTHESIA CONDUCTION KIT |
Manufacturer (Section D) |
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) |
reading PA 19605 |
|
MDR Report Key | 8531448 |
MDR Text Key | 142616935 |
Report Number | MW5085988 |
Device Sequence Number | 1 |
Product Code |
CAZ
|
UDI-Device Identifier | 60801902005139 |
UDI-Public | 60801902005139 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
04/16/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/18/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2020 |
Device Model Number | 19 GAUGE CATHETER |
Device Catalogue Number | AK 05502 |
Device Lot Number | 23F19C0021 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 25 YR |
Patient Weight | 71 |
|
|