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 2019-05-09 for GLIDERITE? SINGLE-USE STYLET 0142-0797 0803-0118 manufactured by Verathon Medical Ulc.
[144846997]
The complaint sample was not returned for investigation, and no images of the stylet could be obtained. Furthermore, no lot number was available to assist in identifying a retention sample for investigation. It was not possible to verify the failure of the gliderite single use stylet. At this time, the cause could not be determined, but it is likely that the straightening of the stylet in the et tube caused or contributed to the event. Corrective action is not required at this time. Verathon will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[144846998]
The customer reported that during a patient procedure using a gliderite single use stylet, a piece of the device had broken off and remained in the lung of the patient. It was noted that the end user of the device attempted to straighten out the stylet in the et tube prior to use, which resulted in the breaking of the stylet. The broken portion of the stylet was later removed and there was no harm to the patient or user reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2019-00074 |
| MDR Report Key | 8596543 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-09 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-04-09 |
| Date Added to Maude | 2019-05-09 |
| 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? SINGLE-USE STYLET |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-05-09 |
| Model Number | 0142-0797 |
| Catalog Number | 0803-0118 |
| 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, BRITISH COLUMBIA V5C 5A9 CA V5C 5A9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |