MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for GLIDE RITE SINGLE USE STYLET SMALL 3.0 - 4.0 REF 0803-0118 manufactured by Verathon, Inc..
[144687048]
Glide-scope go and a 3. 0 uncuffed et tube used for pediatric intubation. During removal of the glide scope rigid stylet from the et tube approximately half the stylet was removed; it then snapped, leaving little more than half of the rigid stylet lodged in the et tube. Remaining half completely removed with forceps. No pt harm. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086507 |
| MDR Report Key | 8597080 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-04-24 |
| Date Added to Maude | 2019-05-09 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GLIDE RITE SINGLE USE STYLET SMALL 3.0 - 4.0 |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-05-09 |
| Catalog Number | REF 0803-0118 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON, INC. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |