MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-25 for TRI-FLO SUBGLOTTIC SUCTION SYSTEM CM28010 manufactured by Vyaire Medical, Inc.
[112173085]
Customer reported sample is not available since it was discarded.
Patient Sequence No: 1, Text Type: N, H10
[112173086]
The customer reported: when introducing the catheter into the oral cavity of a generally sedated (rass -2~-3) patient i had the distal end of the white portion of the introducer break off and separate from the body of the introducer. Customer states device was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00425 |
| MDR Report Key | 7633858 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-25 |
| Date of Report | 2018-06-28 |
| Date of Event | 2018-06-07 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-06-25 |
| 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 | AVERY FOSTER |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO. 85., PARQUE INDUSTRIAL MEX |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRI-FLO SUBGLOTTIC SUCTION SYSTEM |
| Generic Name | CATHETERS, SUCTION, TRACHEOBRONCHIAL, |
| Product Code | OFR |
| Date Received | 2018-06-25 |
| Catalog Number | CM28010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-25 |