MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-02 for B&B MEDICAL 11160 ADULT 11160 manufactured by B&b Medical Technologies, By: Integra Biotechnical, Llc.
[2753595]
The universal site block slipped down deeply into the oropharynx and through it was visibly seen. It was not retrievable. Anesthesia was called immediately and endotracheal tube was promptly removed and the pt was reintubated. Our observation is that the cable tie, though very snug, did not adequately prevent the bite block from slipping down the size #7 endotracheal tube into the oropharynx; no safe guard to prevent potential risk. Additionally, with the newer orders of the site block, we noticed the opening slot is wider which may also possibly be contributory.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025286 |
| MDR Report Key | 2561692 |
| Date Received | 2012-05-02 |
| Date of Report | 2012-04-18 |
| Date of Event | 2012-04-01 |
| Date Added to Maude | 2012-05-08 |
| 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 |
| 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 | B&B MEDICAL |
| Generic Name | UNIVERSAL SITE BLOCK |
| Product Code | JXL |
| Date Received | 2012-05-02 |
| Model Number | 11160 ADULT |
| Catalog Number | 11160 |
| Lot Number | D134204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B&B MEDICAL TECHNOLOGIES, BY: INTEGRA BIOTECHNICAL, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-02 |