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 2018-05-16 for GLIDERITE RIGID STYLET 0270-0681 manufactured by Verathon Medical Ulc.
[108729010]
The rigid stylet was returned to verathon for evaluation. The technical service representative confirmed the reported damage to the stylet and noted the handle detached from the stylet shaft. The customer indicated, during a follow up call, that the lot number of the stylet was not known, and that the last purchase date was in 2016. The customer also stated the facility sterilized the stylet for 10 minutes at 275 degrees fahrenheit (135 degrees celsius) in a prevac steam sterilizer autoclave, which is an approved sterilization method according to the instructions for use (ifu). The customer was unaware of how many sterilization cycles this stylet has received. The exact cause could not be determined, however, it is likely based on the last purchase date and estimated stylet usage that the stylet exceeded the approved number of sterilization cycles as indicated in the ifu.
Patient Sequence No: 1, Text Type: N, H10
[108729171]
The customer reported that the gliderite rigid stylet broke in the endotracheal tube during a patient procedure. The procedure was completed with a backup stylet; however, the time required to prepare the second stylet was not reported. No harm to patient or user reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2018-00070 |
| MDR Report Key | 7517998 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-16 |
| Date of Report | 2018-04-19 |
| Date of Event | 2018-04-19 |
| Date Mfgr Received | 2018-04-19 |
| Date Added to Maude | 2018-05-16 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | 2018-05-16 |
| Returned To Mfg | 2018-04-26 |
| Model Number | 0270-0681 |
| Catalog Number | 0270-0681 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-05-16 |