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 2018-11-28 for GLIDERITE RIGID STYLET 0270-0681 manufactured by Verathon Medical Ulc.
[129204700]
A verathon sales representative inspected the ridged stylet at the customer's facility and confirmed the reported damage. He also found that the lot number of the stylet was 0316, indicating the stylet was manufactured in march of 2016. After inspecting the device, the sales representative removed the device from service to prevent further use. Per the ifu, the stylet has an expected life based on sterilization and disinfection method used by the customer. As the device has not been returned, the root cause cannot be conclusively determined. However, it is likely that due to the age of the device (>2 years) the recommended number of sterilization cycles has been exceeded. Verathon has requested additional information from the customer on their sterilization method and cycles for this stylet; however, have not yet received a response. 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
[129204701]
The customer reported that their gliderite rigid stylet separated where the base of the handle meets the thinner blue plastic during a patient procedure. The stylet had already been inserted in the tube so they were able to complete the procedure with the device; however, forceps needed to be used to remove the stylet from the endotracheal tube. The procedure was delayed for approximately one minute while the shaft of the stylet was removed. No harm to patient or user reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2018-00174 |
| MDR Report Key | 8113834 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-28 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-10-29 |
| Date Mfgr Received | 2018-10-29 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2018-11-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-11-28 |
| Model Number | 0270-0681 |
| Catalog Number | 0270-0681 |
| Lot Number | 0316 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-11-28 |