MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-02-19 for INTRODUCER (BOUGIE) 9-0212-70 manufactured by Meditec Devices.
[1408601]
Endotracheal tube introducer was used to exchange the endotracheal tube that was placed in pt's trachea. Pt's airway was difficult. Once placed in the endotracheal tube, the introducer broke into two pieces. All contents of the blue endotracheal tube were removed with the endotracheal tube under direct laryngoscope. Another blue endotracheal tube was used without difficulty to place a new endotracheal tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036445-2010-01016 |
| MDR Report Key | 1746145 |
| Report Source | 99 |
| Date Received | 2010-02-19 |
| Date of Report | 2010-02-18 |
| Date of Event | 2010-01-10 |
| Date Facility Aware | 2010-01-25 |
| Report Date | 2010-02-19 |
| Date Reported to FDA | 2010-02-19 |
| Date Reported to Mfgr | 2010-02-19 |
| Date Added to Maude | 2011-06-23 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRODUCER (BOUGIE) |
| Generic Name | ENDOTRACHEAL TUBE INTRODUCER |
| Product Code | BWB |
| Date Received | 2010-02-19 |
| Model Number | 9-0212-70 |
| Catalog Number | 9-0212-70 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDITEC DEVICES |
| Manufacturer Address | 2A MITUL IND. ESTATE SATIVALI RD VASAI (E), THANE, MAHARASHTRA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-19 |