MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-23 for BIVONA? ADULT TTS? TRACHEOSTOMY TUBE COMPNNA manufactured by Smiths Medical Asd,inc..
[184632799]
No serial number information on device. No reports of which device it is. Source of reporting left out detailed information. A lot of blanks on this report as no information provided.
Patient Sequence No: 1, Text Type: N, H10
[184632800]
Information was received that smiths tracheostomy tube has a reportable event, as during trach change it was difficult to remove as the blue end came away from the tube causing difficulty removing tube. This would be a compromise in airway control and possible obstruction. No reports of additional intervention required. ?
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02197 |
| MDR Report Key | 9869272 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD,INC |
| Manufacturer Street | 6000 LANE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIVONA? ADULT TTS? TRACHEOSTOMY TUBE |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-23 |
| Model Number | COMPNNA |
| Operator | LAY USER/PATIENT |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |