MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-20 for B&B MEDICAL TECHNOLOGIES - UNIVERSAL BITE BLOCK FOR TUBE SIZE 6MM TO 9.5 MM 11160 manufactured by Integra Biotechnical, Llc.
[16748460]
Respiratory therapist (rt) and a rn witnessed that the "protective blue piece" at the end of the stiff tie on the bite block had fallen off and landed in a patient's mouth. Rt supervisor checked the device and found that the tip does indeed dislodge fairly easily. Had it not been for rt and rn attention to detail, that piece could have been aspirated by the patient with potentially disastrous consequences. This event has occurred on more than one occasion resulting in near aspiration of the small part.
Patient Sequence No: 1, Text Type: D, B5
[16874041]
Respiratory therapist (rt) and a rn witnessed that the "protective blue piece" at the end of the stiff tie on the bite block had fallen off and landed in a patient's mouth. Rt supervisor checked the device and found that the tip does indeed dislodge fairly easily. Had it not been for rt and rn attention to detail, that piece could have been aspirated by the patient with potentially disastrous consequences. This event has occurred on more than one occassion resulting in near aspiration of the small part.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2875032 |
| MDR Report Key | 2875032 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-11-20 |
| Date of Event | 2012-11-08 |
| Report Date | 2012-11-20 |
| Date Reported to FDA | 2012-11-20 |
| Date Added to Maude | 2012-12-17 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | B&B MEDICAL TECHNOLOGIES - UNIVERSAL BITE BLOCK |
| Generic Name | ENDOSCOPIC BITE BLOCK |
| Product Code | JXL |
| Date Received | 2012-11-20 |
| Model Number | FOR TUBE SIZE 6MM TO 9.5 MM |
| Catalog Number | 11160 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BIOTECHNICAL, LLC |
| Manufacturer Address | 2755 DOS AARONS WAY, SUITE B VISTA CA 92081 US 92081 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-20 |