MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-17 for SHILEY manufactured by Covidien Llc.
[183695043]
Patient was being intubated with tapergard subglottic endotracheal tubes. Cuff did not hold air, so patient needed to be reintubated. Unclear if this is an equipment failure or anatomy issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9840704 |
| MDR Report Key | 9840704 |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-28 |
| Report Date | 2020-03-09 |
| Date Reported to FDA | 2020-03-09 |
| Date Reported to Mfgr | 2020-03-17 |
| Date Added to Maude | 2020-03-17 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHILEY |
| Generic Name | TUBE, TRACHEAL (W/WO CONNECTOR) |
| Product Code | BTR |
| Date Received | 2020-03-17 |
| Lot Number | 19A0830JZX/19J1007JZX |
| Device Availability | * |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |