MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-02-09 for PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE manufactured by Smiths Medical Asd, Inc..
[178325045]
Report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[178325046]
Information was received that clamp that secures the tube on a smiths medical portex adjustable flange tracheostomy tube was not holding and loosened. Patient was in distress. Unplanned tracheostomy performed. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00956 |
| MDR Report Key | 9685107 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-09 |
| Date of Report | 2020-02-09 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-02-09 |
| 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 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE |
| Generic Name | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO |
| Product Code | BTO |
| Date Received | 2020-02-09 |
| 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 | 2020-02-09 |