MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-04 for GLIDERITE RIGID STYLET 0270-0681 manufactured by Verathon Medical Ulc.
[97104650]
At the time of this report the gliderite rigid stylet has not been received by verathon, however; the return of the device is anticipated. Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803. 56 when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[97104651]
The customer reported that the handle of a gliderite rigid stylet broke and a piece fell into the endotracheal tube during a patient procedure. The piece of the stylet was removed from the endotracheal tube with no harm to patient or user reported. The procedure was completed with a backup stylet; however, the time required to prepare the second stylet was not reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2018-00001 |
| MDR Report Key | 7166342 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-04 |
| Date of Report | 2017-12-07 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2017-12-07 |
| Date Added to Maude | 2018-01-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. COREY KASBOHM |
| Manufacturer Street | 20001 N CREEK PKWY |
| Manufacturer City | BOTHELL WA 980118218 |
| Manufacturer Country | US |
| Manufacturer Postal | 980118218 |
| Manufacturer Phone | 4256295760 |
| Manufacturer G1 | VERATHON MEDICAL ULC |
| Manufacturer Street | 2227 DOUGLAS ROAD |
| Manufacturer City | BURNABY, BRITISH COLUMBIA V5C 5A9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | V5C 5A9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLIDERITE RIGID STYLET |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2018-01-04 |
| Model Number | 0270-0681 |
| Catalog Number | 0270-0681 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON MEDICAL ULC |
| Manufacturer Address | 2227 DOUGLAS ROAD BURNABY, BRITISH COLUMBIA V5C 5A9 CA V5C 5A9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-04 |