MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-27 for PORTEX? ENDOBRONCHIAL TUBE 198-37L manufactured by Smiths Medical Asd; Inc..
[168318577]
Information was received indicating that leakage of air was observed immediately following placement of a smiths medical portex? Endobronchial tube. It was reported that positive pressure ventilation occurred following intubation. The patient is edentulous which is noted to not cause tube damage. There were no reported adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-07105 |
| MDR Report Key | 9386989 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2019-11-18 |
| Device Manufacturer Date | 2019-06-04 |
| Date Added to Maude | 2019-11-27 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, CT216JL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CT21 6JL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX? ENDOBRONCHIAL TUBE |
| Generic Name | TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR) |
| Product Code | CBI |
| Date Received | 2019-11-27 |
| Returned To Mfg | 2019-11-29 |
| Catalog Number | 198-37L |
| Lot Number | 3792387 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-27 |