| Device |
stylet for catheter, gastro-urology |
| Regulation Description |
Urological catheter and accessories. |
| Product Code | EZB |
| Regulation Number |
876.5130
|
|---|
| Device Class |
1
|
| Device Problems |
| Peeled |
234 |
| Detachment of device component |
225 |
| Device damaged prior to use |
58 |
| Tip breakage |
53 |
| Device, or device fragments remain in patient |
49 |
| Break |
41 |
| Flaked |
37 |
| Other (for use when an appropriate device code cannot be identified) |
31 |
| Failure to advance |
22 |
| Difficult to remove |
22 |
| Source, detachment from |
22 |
| Material frayed |
21 |
| Wire(s), breakage of |
21 |
| Tears, rips, holes in device, device material |
20 |
| Difficult to insert |
17 |
| No Known Device Problem |
16 |
| Detachment of device or device component |
15 |
| Physical resistance |
12 |
| Unknown (for use when the device problem is not known) |
11 |
| Kinked |
11 |
| Unraveled material |
10 |
| Fracture |
8 |
| Loose |
8 |
| Split |
7 |
| Sharp/jagged/rough/etched/scratched |
5 |
| Material separation |
5 |
| Stretched |
5 |
| Material fragmentation |
4 |
| Defective item |
4 |
| Difficult to advance |
4 |
| Device Issue |
4 |
| Fitting problem |
3 |
| Incorrect device or component shipped |
3 |
| Device, removal of (non-implant) |
3 |
| No code available |
3 |
| Component(s), broken |
3 |
| Bent |
3 |
| Difficult to position |
3 |
| Mislabeled |
2 |
| Normal |
2 |
| Retraction problem |
2 |
| Device expiration issue |
2 |
| Foreign material |
2 |
| Device or device fragments location unknown |
2 |
| Uncoiled |
2 |
| Device inoperable |
2 |
| Component missing |
2 |
| Incomplete or missing packaging |
1 |
| Tube(s), buckling of |
1 |
| Dull |
1 |
| Tracking |
1 |
| Wrinkled |
1 |
| Device or device component damaged by another device |
1 |
| Device packaging compromised |
1 |
| Torn material |
1 |
| No Information |
1 |
| Knotted |
1 |
| Interference |
1 |
| Abnormal |
1 |
| Crack |
1 |
| Dislodged |
1 |
| Blockage within device or device component |
1 |
| Pierce |
1 |
| Unsealed device packaging |
1 |
| Misplacement |
1 |
| Shaft, split |
1 |
| Size incorrect for patient |
1 |
| Specificity |
1 |
| Sterility |
1 |
| Sticking |
1 |
| Total Device Problems |
1064 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
