Brand Name | ACCUCATH INTRAVASCULAR CATHETER 18G |
Type of Device | CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS |
Manufacturer (Section D) |
BARD ACCESS SYSTEMS, INC. |
salt lake city UT 84116 |
|
MDR Report Key | 8615644 |
MDR Text Key | 145373483 |
Report Number | MW5086672 |
Device Sequence Number | 1 |
Product Code |
FOZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
05/14/2019 |
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 Model Number | 18GX2.25IN |
Device Catalogue Number | ACO182250 |
Device Lot Number | RECU0738 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/14/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 05/15/2019 |
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 | 46 YR |
Patient Weight | 142 |
|
|