MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-27 for PORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBE 670170 manufactured by Smiths Medical Asd; Inc..
[185482342]
Information was received indicating that two weeks following placement of a smiths medical portex? Bivona? Adult tts? Tracheostomy (trach) tube, the patient had breathing difficulties. Subsequently, the trach tube was changed out and the patient recovered. It was reported that the cuff was noted to have a leak. There were no further adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02380 |
| MDR Report Key | 9892385 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-03-27 |
| 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 ASD; INC. |
| Manufacturer Street | 6000 NATHAN 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 | PORTEX? BIVONA? ADULT TTS? TRACHEOSTOMY TUBE |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 670170 |
| Catalog Number | 670170 |
| Lot Number | 3856200 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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. Life Threatening; 2. Required No Informationntervention | 2020-03-27 |