MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-20 for ADULT UNIVERSAL BITE BLOCK REF #11160 UNKNOWN manufactured by B & B Medical Technologies.
[18838674]
Rn informed respiratory therapist that she observed a little blue piece of plastic disappear into the patient's nare. At the time the patient was intubated and sedated. Respiratory therapist was able to visualize object with flashlight and remove it with tweezers. Object identified as the bite block blue silicon cover placed on the end of the bite block holder. The cable was not cut before the blue cap was placed over it. ====================== health professional's impression======================the blue cap is too loose. It shouldn't be able to slip off that easily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1775091 |
| MDR Report Key | 1775091 |
| Date Received | 2010-07-20 |
| Date of Report | 2010-07-20 |
| Date of Event | 2010-07-18 |
| Report Date | 2010-07-20 |
| Date Reported to FDA | 2010-07-20 |
| Date Added to Maude | 2010-07-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT UNIVERSAL BITE BLOCK REF #11160 |
| Generic Name | BLOCK, BITE |
| Product Code | JXL |
| Date Received | 2010-07-20 |
| Model Number | 11160 |
| Catalog Number | UNKNOWN |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B & B MEDICAL TECHNOLOGIES |
| Manufacturer Address | 2734 LOKER AVENUE WEST, SUITE M CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-20 |