MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-09-18 for GLIDERITE? SINGLE-USE STYLET 0270-0681 manufactured by Verathon Medical Ulc.
[159360985]
The gliderite ridged stylet has not been returned to verathon at this time. The customer did not respond to verathon's requests for additional information on the number of sterilization cycles and method for this device. The customer also declined the option to have their stylet returned to verathon for evaluation. Because the lot number of the stylet used during the procedure was not known and the complaint sample was not returned, the cause of the reported issue could not be determined. No corrective action is required at this time. Verathon will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[159360986]
The customer reported that during a patient procedure using a gliderite ridged stylet, a piece of the device had broken off and remained in the endotracheal tube (ett). The end user was unable to remove the stylet from the ett; therefore, another ett and stylet were used to complete the procedure. No harm to the patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2019-00121 |
| MDR Report Key | 9084348 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-09-18 |
| Date of Report | 2019-07-23 |
| Date of Event | 2019-07-22 |
| Date Mfgr Received | 2019-07-23 |
| Date Added to Maude | 2019-09-18 |
| 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, 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 | 2019-09-18 |
| 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, V5C 5A9 CA V5C 5A9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-18 |