MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-09 for BITE PROOF BITE BLOCK manufactured by B And B Medical Technologies.
[19365258]
Bite proof bite block for endotracheal tubes size 6 to 9. 5mm was used. Mfg by integra biotechnical, llc for b and b medical technologies. Lot # d133437. The tubing from the pilot balloon port was placed between the ett and the bite block per mfr instructions. The tubing became kinked and the balloon could not be inflated. The ett had to be removed and the pt was re-intubated. The pt died on (b)(6) 2012, but it is unclear if the kinked tube had a significant role in the outcome. However, the fact remains that the medical staff had to re-intubate the pt with a new ett and when examining the ett that was initially used it was found that the tube was kinked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025384 |
| MDR Report Key | 2578399 |
| Date Received | 2012-05-09 |
| Date of Report | 2012-05-09 |
| Date of Event | 2012-04-18 |
| Date Added to Maude | 2012-05-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | BITE PROOF BITE BLOCK |
| Generic Name | BITE BLOCK |
| Product Code | JXL |
| Date Received | 2012-05-09 |
| Returned To Mfg | 2012-05-09 |
| Lot Number | D133437 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B AND B MEDICAL TECHNOLOGIES |
| Manufacturer Address | CARLSBAD CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-05-09 |