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 2018-11-14 for GLIDERITE RIGID STYLET 0270-0681 manufactured by Verathon Medical Ulc.
[128050659]
A verathon complaints specialist followed up with the customer to gather additional information. The customer stated the lot number of the stylet was 0515, indicating the stylet was manufactured in may of 2015. The customer also noted that their facility autoclaves their stylets at 270 degrees for 4 minutes, which is an approved sterilization method for up to 300 cycles according to the instructions for use (ifu). The customer was unaware of how many sterilization cycles this stylet has received. The gliderite ifu states: "do not use this product if the device appears damaged; inspect before use. ". At the time of this report the device has not been returned to verathon for evaluation, 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 is made available.
Patient Sequence No: 1, Text Type: N, H10
[128050660]
The customer reported that the plastic portion of their gliderite ridgid stylet broke during a patient procedure. The nurse who reported the issue stated that she believed the handle of the stylet was cracked prior to use. The procedure was completed; however, it is not known what device was used to complete the procedure. No harm to the patient or user was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2018-00171 |
| MDR Report Key | 8069385 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-14 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-11-14 |
| 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 | 2018-11-14 |
| Returned To Mfg | 2018-11-15 |
| Model Number | 0270-0681 |
| Catalog Number | 0270-0681 |
| Lot Number | 0515 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-11-14 |