MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-03-30 for BIVONA * B10100 manufactured by Smiths Medical Asd, Inc..
[338003]
Used the nu-trake last night on a pt and the dr reported that it broke and he had to manually retrieve a piece from the pt's trachea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1824231-2004-00004 |
| MDR Report Key | 538292 |
| Report Source | 05,06 |
| Date Received | 2004-03-30 |
| Date of Report | 2004-03-29 |
| Date of Event | 2004-03-11 |
| Date Mfgr Received | 2004-03-12 |
| Date Added to Maude | 2004-08-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 5700 W. 23RD AVE |
| Manufacturer City | GARY IN 46406 |
| Manufacturer Country | US |
| Manufacturer Postal | 46406 |
| Manufacturer Phone | 2199899150 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIVONA |
| Generic Name | CRICOTHYROTOMY DEVICE |
| Product Code | BWC |
| Date Received | 2004-03-30 |
| Model Number | * |
| Catalog Number | B10100 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 527540 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | * GARY IN * US |
| Baseline Brand Name | BIVONA |
| Baseline Catalog No | B10100 |
| Baseline Device Family | NU-TRAKE ADULT CRICOTHYROTOMY DEVICE |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K790650 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-30 |