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 2020-03-11 for PORTEX? UNIPERC? ADJUSTABLE FLANGE TRACHEOSTOMY TUBE 100/897/090 manufactured by Smiths Medical Asd; Inc..
[183106126]
Information was received indicating that the connector to a smiths medical portex? Uniperc? Adjustable flange tracheostomy tube was disconnecting from the tube 11 days following placement. Subsequently, a trach tube change out was performed. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01869 |
| MDR Report Key | 9821035 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2019-12-05 |
| Date Added to Maude | 2020-03-11 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | BOUNDARY ROAD |
| Manufacturer City | HYTHE, KENT 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 | 2020-03-11 |
| Model Number | 100/897/090 |
| Catalog Number | 100/897/090 |
| Lot Number | 3886456 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-11 |