| Device Type ID | 2626 |
| Device Name | Device, Intravascular Catheter Securement |
| Regulation Description | Intravascular Catheter Securement Device. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5210 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KMK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2626 |
| Device | Device, Intravascular Catheter Securement |
| Product Code | KMK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Intravascular Catheter Securement Device. |
| CFR Regulation Number | 880.5210 [🔎] |
| Device Problems | |
|---|---|
Loss Of Or Failure To Bond | 33 |
Adverse Event Without Identified Device Or Use Problem | 11 |
Device Disinfection Or Sterilization Issue | 10 |
Delivered As Unsterile Product | 9 |
Use Of Device Problem | 5 |
Failure To Adhere Or Bond | 4 |
Mechanical Problem | 3 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Failure To Disinfect | 2 |
Unsealed Device Packaging | 2 |
Patient Device Interaction Problem | 2 |
Material Integrity Problem | 2 |
Compatibility Problem | 1 |
Patient-Device Incompatibility | 1 |
Physical Property Issue | 1 |
Device Issue | 1 |
Mechanics Altered | 1 |
Torn Material | 1 |
| Total Device Problems | 91 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bard Access Systems | II | Jan-10-2017 |
| 2 | Bard Access Systems Inc. | II | May-19-2017 |