MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-02-15 for B & B MEDICAL ADULT #11160 11160 manufactured by B & B Medical Technologies, Inc./integra Biotechnical, Llc.
[1461939]
Male burn patient was very restless and agitated after debridement surgery. The patient was trying to pull out the endotracheal tube. The patient was biting the tube aggressively so the rt and the rn attempted to place a universal bite block. The bite block has a zip tie end which is attached to the block. The end of the zip tie has a plastic blue cap (possibly to keep it from poking through the packaging). The plastic blue cap fell off the tip and landed in the patient's mouth. The rt and the rn attempted to retrieve it but it disappeared. It is presumed the patient swallowed it. The staff will monitor the patient's bowel movements in the meantime. A xray was obtained. Unfortunately, the cap is not radiopaque, so it could not be found on x-ray. Although the patient is now extubated and breathing well, aspiration cannot be completely ruled out. However, it is not believed that the patient aspirated this cap. The patient still had the et tube cuff inflated so it would have been difficult for the cap to pass the cuff. The surrounding areas were searched and the cap was not located. The packaging does not have any indication listed about removing cap before use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1614222 |
| MDR Report Key | 1614222 |
| Date Received | 2010-02-15 |
| Date of Report | 2010-02-15 |
| Date of Event | 2010-02-04 |
| Report Date | 2010-02-15 |
| Date Reported to FDA | 2010-02-15 |
| Date Added to Maude | 2010-02-24 |
| 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 | B & B MEDICAL |
| Generic Name | ADULT UNIVERSAL BITE BLOCK |
| Product Code | JXL |
| Date Received | 2010-02-15 |
| Model Number | ADULT #11160 |
| Catalog Number | 11160 |
| Lot Number | 051107 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B & B MEDICAL TECHNOLOGIES, INC./INTEGRA BIOTECHNICAL, LLC |
| Manufacturer Address | 2734 LOKER AVENUE WEST SUITE M CARLSBAD CA 92010 US 92010 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-15 |