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 2020-02-26 for PORTEX? UNIPERC? ADJUSTABLE FLANGE TRACHEOSTOMY TUBE 100/897/080 manufactured by Smiths Medical Asd; Inc..
[180901320]
Information was received indicating that the locking mechanism to a smiths medical portex? Uniperc? Adjustable flange tracheostomy tube was noted to malfunction; leaving the tube susceptible to being displaced. It was reported that the tube slide in and out while the patient was being mechanically ventilated. Subsequently, the tube was immediately replaced. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01517 |
| MDR Report Key | 9753993 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-02-26 |
| 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? UNIPERC? ADJUSTABLE FLANGE TRACHEOSTOMY TUBE |
| Generic Name | TUBE, TRACHEOSTOMY (W/WO CONNECTOR) |
| Product Code | BTO |
| Date Received | 2020-02-26 |
| Model Number | 100/897/080 |
| Catalog Number | 100/897/080 |
| Lot Number | 3645624 |
| 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 N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |