MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-10 for BITE PROOF BITE BLOCK manufactured by B&b Medical Technologies.
[2650723]
During planned extubation the ett could not be withdrawn. Cuff deflated x2 and still could not withdraw. Cut line to port used to inflate and then withdrew ett. Balloon still had some air in it. The tube was found to be pinched between the ett and the bite proof bite bock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025386 |
| MDR Report Key | 2578410 |
| Date Received | 2012-05-10 |
| Date of Report | 2012-05-10 |
| Date of Event | 2012-04-08 |
| Date Added to Maude | 2012-05-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE PROOF BITE BLOCK |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2012-05-10 |
| Lot Number | D133437 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B&B MEDICAL TECHNOLOGIES |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-10 |