MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-27 for PORTEX BIVONA TRACHEOSTOMY TUBE manufactured by Smiths Medical Asd; Inc..
[185195596]
Information was received indicating that immediately following placement of a smiths medical portex bivona tracheostomy (trach) tube, the ventilator alarm occurred. A trach tube change out was performed. Following removal of the defective tube, it was found that the cuff was not inflating. Air was inserted into the pilot balloon, but the cuff would not inflate. There were no reported adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02201 |
| MDR Report Key | 9887342 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-02-24 |
| 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 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 BIVONA TRACHEOSTOMY TUBE |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-27 |
| 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 | 2020-03-27 |