| Device Type ID | 5948 |
| Device Name | Sealant, Polymerizing |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | NBE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5948 |
| Device | Sealant, Polymerizing |
| Product Code | NBE |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 40 |
Break | 12 |
Complete Blockage | 5 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Improper Or Incorrect Procedure Or Method | 4 |
Crack | 4 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 4 |
Shelf Life Exceeded | 1 |
Fluid Leak | 1 |
Housing | 1 |
Leak / Splash | 1 |
Port | 1 |
Expiration Date Error | 1 |
Device Operates Differently Than Expected | 1 |
Infusion Or Flow Problem | 1 |
Syringe | 1 |
Loss Of Or Failure To Bond | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 85 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Baxter Healthcare Corp | II | May-31-2016 |
| 2 | Mallinckrodt Manufacturing LLC | II | Jul-06-2017 |