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 2019-03-27 for GLIDERITE? SINGLE-USE STYLET 0142-0797 0803-0118 manufactured by Verathon Medical Ulc.
[140122276]
The customer indicated the stylet has been shipped to verathon for evaluation; however at the time of this report the device has not been received. 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
[140122317]
The customer reported that during a patient procedure, using a gliderite single use stylet, while removing the stylet from a 4. 0mm endotracheal (et) tube it broke. The customer indicated the procedure was completed; however, type of device used to complete the procedure and the length of time to prepare the second device were not reported. No harm to the patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2019-00046 |
| MDR Report Key | 8458209 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-27 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-02-26 |
| Device Manufacturer Date | 2018-04-23 |
| Date Added to Maude | 2019-03-27 |
| 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? SINGLE-USE STYLET |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-03-27 |
| Model Number | 0142-0797 |
| Catalog Number | 0803-0118 |
| Lot Number | GS45915 |
| 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 | 2019-03-27 |