MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-15 for GLIDERITE SINGLE-USE STYLET SMALL 3.0-4.0MM 0803-0118 manufactured by Verathon Medical.
[136298172]
During intubation of patient at outside hospital by the transport team, the stylet broke off within the endotracheal tube. The patient was ventilating and oxygenating well upon arrival at the hospital. The broken stylet did not appear on the x-ray and was not discovered until the endotracheal tube was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8343902 |
| MDR Report Key | 8343902 |
| Date Received | 2019-02-15 |
| Date of Report | 2019-02-08 |
| Date of Event | 2019-01-25 |
| Report Date | 2019-02-08 |
| Date Reported to FDA | 2019-02-08 |
| Date Reported to Mfgr | 2019-02-15 |
| Date Added to Maude | 2019-02-15 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | GLIDERITE SINGLE-USE STYLET SMALL 3.0-4.0MM |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-02-15 |
| Model Number | 0803-0118 |
| Catalog Number | 0803-0118 |
| Lot Number | GS43228 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON MEDICAL |
| Manufacturer Address | 20001 NORTH CREEK PARKWAY BOTHELL WA 98011 US 98011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |