MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-01-31 for PORTEX ENDOBRONCHIAL TUBE 198-32L manufactured by Smiths Medical Asd, Inc..
[177230074]
Foreign - report source: (b)(6). (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[177230075]
Information was received that a smiths medical portex endobronchial tube was in use with a patient at the hospital. The patient was reported to have an unspecified pleural effusion and immediately upon placement had difficulty handling and passing the tube due to its curvature and noted "harder material". Subsequently, another tube of the same brand was used. The patient had no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00649 |
| MDR Report Key | 9655278 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-31 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2018-08-03 |
| Date Added to Maude | 2020-01-31 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD, HYTHE KENT CT21 6JL |
| Manufacturer City | KENT, |
| Manufacturer Country | UK |
| 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 | 2020-01-31 |
| Model Number | 198-32L |
| Catalog Number | 198-32L |
| Lot Number | 3666497 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-31 |