MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for BITE PROOF BITE BLOCK 11160 manufactured by B & B Medical Technologies, Inc..
[66060106]
Patient Sequence No: 1, Text Type: N, H10
[66060107]
While et tube was being advanced, patient became agitated and the blue cap on the zip tie that holds the hollister endotracheal tube holder (bite block) fell into patient's mouth. Rn and respiratory therapist used flashlight to try to locate cap without success. The doctor was notified and ent consult ordered. Before ent arrived, the patient coughed and cap was then visible in mouth and was removed. No harm to patient. Being discussed in systemwide rt mtg re danger of this small tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6285520 |
| MDR Report Key | 6285520 |
| Date Received | 2017-01-30 |
| Date of Report | 2017-01-18 |
| Date of Event | 2016-12-22 |
| Report Date | 2017-01-18 |
| Date Reported to FDA | 2017-01-18 |
| Date Reported to Mfgr | 2017-01-18 |
| Date Added to Maude | 2017-01-30 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BITE PROOF BITE BLOCK |
| Generic Name | SUPPORT, BREATHING TUBE |
| Product Code | JAY |
| Date Received | 2017-01-30 |
| Catalog Number | 11160 |
| Lot Number | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B & B MEDICAL TECHNOLOGIES, INC. |
| Manufacturer Address | 1954 KELLOGG AVE. SUITE 100 CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-30 |