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 2019-05-31 for GLIDERITE? SINGLE-USE STYLET 0142-0797 0803-0118 manufactured by Verathon Medical Ulc.
[146662710]
The gliderite single use stylet was returned to verathon for further evaluation. A verathon complaints specialist evaluated the returned stylet where they were able to verify the reported issue. It was found that the stylet had broken into two pieces. The returned stylet was forwarded to verathon engineering for further evaluation. Once the device evaluation is complete, a supplemental report will be submitted in accordance with 21 cfr 803. 56 with the additional information.
Patient Sequence No: 1, Text Type: N, H10
[146662711]
The customer reported that during a patient procedure using a gliderite single use stylet, a piece of the device had broken off and slide down the endotracheal tube (ett). The end user was able to remove the broken portion from the et tube and there was no harm to the patient or user reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2019-00089 |
| MDR Report Key | 8658616 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-05-01 |
| Date Mfgr Received | 2019-05-01 |
| Date Added to Maude | 2019-05-31 |
| 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, 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 | 2019-05-31 |
| Returned To Mfg | 2019-05-14 |
| Model Number | 0142-0797 |
| Catalog Number | 0803-0118 |
| 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, V5C 5A9 CA V5C 5A9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-31 |