| Device Type ID | 1994 |
| Device Name | Catheter, Urological (antimicrobial) And Accessories |
| Regulation Description | Urological Catheter And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5130 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MJC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1994 |
| Device | Catheter, Urological (antimicrobial) And Accessories |
| Product Code | MJC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Urological Catheter And Accessories. |
| CFR Regulation Number | 876.5130 [🔎] |
| Device Problems | |
|---|---|
Failure To Infuse | 87 |
Break | 55 |
Product Quality Problem | 32 |
Inaccurate Flow Rate | 26 |
Device Damaged Prior To Use | 23 |
Incorrect Measurement | 22 |
Defective Component | 21 |
Patient-Device Incompatibility | 19 |
Restricted Flow Rate | 18 |
Deflation Problem | 17 |
Erratic Or Intermittent Display | 16 |
Short Fill | 13 |
Gel Leak | 13 |
Leak / Splash | 13 |
Device Contamination With Chemical Or Other Material | 11 |
Tear, Rip Or Hole In Device Packaging | 11 |
Misassembled | 10 |
Deformation Due To Compressive Stress | 9 |
Partial Blockage | 9 |
Material Twisted / Bent | 8 |
Material Rupture | 7 |
Difficult To Insert | 6 |
Disconnection | 5 |
Mushroomed | 5 |
Material Invagination | 5 |
Difficult To Remove | 4 |
Material Deformation | 4 |
Nonstandard Device | 3 |
Burst Container Or Vessel | 2 |
Material Integrity Problem | 2 |
Inadequate Instructions For Healthcare Professional | 2 |
Component Missing | 2 |
Catheter | 2 |
Degraded | 1 |
Device Dislodged Or Dislocated | 1 |
No Flow | 1 |
Melted | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Bags | 1 |
Premature Discharge Of Battery | 1 |
Improper Flow Or Infusion | 1 |
Insufficient Information | 1 |
Collapse | 1 |
Kinked | 1 |
Knotted | 1 |
Sticking | 1 |
Fitting Problem | 1 |
Material Separation | 1 |
| Total Device Problems | 497 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bard Medical Division | II | Feb-06-2019 |
| 2 | Bard Medical Division | II | Feb-05-2019 |
| 3 | C.R. Bard, Inc. | II | Oct-11-2018 |
| 4 | C.R. Bard, Inc. | II | Nov-17-2016 |
| 5 | C.R. Bard, Inc. | II | Apr-08-2016 |
| 6 | C.R. Bard, Inc. | III | Nov-02-2015 |