MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-30 for UNIVERSAL BITE BLOCK 11160 manufactured by B&b Medical Technologies/integra Biotechnical, Llc..
[16047687]
Respiratory therapist 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 pt'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 pt with potentially disastrous consequences. This event has occurred on more than on occasion resulting in near aspiration of the small part. Device usage problem: other.
Patient Sequence No: 1, Text Type: D, B5
[16430498]
After reviewing the anecdotal report submitted by the user and a comprehensive review and statistical analysis of the device history records, spanning back three (3) yrs for this device, we have determined the following: the complaint rate is two (2), including this complaint, in 421,000. The other was of a similar nature, the cap was found in the pt's mouth. That's a complaint rate of. 00000475%. This statistically demonstrates the safety and efficacy of the product. After reviewing of the device history records, lot# d224213 showed that there were no issues or deviations during production and quality inspection results were acceptable. Based on all the info provided to us, we believe one of the following three (3) events may have occurred: the cap was not securely installed, as our i. F. U. Indicates it must be. The pt reached up and dislodged the cap, in which case the pt should have been restrained to prevent this or other issues, such as disrupting an i. V. , o2 supply, etc. Both event 1 and 2 occurred concurrently. We have determined no corrective action is warranted for the device or the i. F. U. We regard this as an isolated incidence of a user failing to follow the i. F. U. And/or sound r. T. Practices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2938401-2012-00004 |
| MDR Report Key | 3001268 |
| Report Source | 06 |
| Date Received | 2013-01-30 |
| Date of Report | 2013-01-25 |
| Date of Event | 2012-11-08 |
| Date Mfgr Received | 2012-12-26 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1954 KELLOGG AVE. SUITE 100 |
| Manufacturer City | CARLSBAD CA 92008 |
| Manufacturer Country | US |
| Manufacturer Postal | 92008 |
| Manufacturer G1 | B&B MEDICAL TECHNOLOGIES/INTEGRA BIOTECHNICAL, LLC |
| Manufacturer Street | 2755 DOS AARONS WAY # B |
| Manufacturer City | VISTA CA 92081 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92081 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL BITE BLOCK |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2013-01-30 |
| Model Number | 11160 |
| Lot Number | D224213 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B&B MEDICAL TECHNOLOGIES/INTEGRA BIOTECHNICAL, LLC. |
| Manufacturer Address | 1954 KELLOGG AVENUE CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-01-30 |