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 TRACHEOSTOMY TUBE 67PFSS40 manufactured by Smiths Medical Asd; Inc..
[185480576]
One bivona tracheostomy (trach) tube was returned for analysis in used conditions. The tube was visually inspected; no discrepancies noted. The sample was filled with air; noting the cuff inflated uniformly. The cuff was inflated and deflated 4 additional times; the cuff inflated properly each time. The manufacturing process and assembly process were both reviewed; no discrepancies. Verification of manufacturing process of the air way and balloon was performed on 32 units; all performed correctly. Based on the evidence there was no fault found as the complaint was not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[185480577]
Information was received indicating that the cuff to a smiths medical portex bivona tracheostomy (trach) tube was reported to not stay inflated during use. The trach was returned for analysis. There were no reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02375 |
| MDR Report Key | 9892389 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-27 |
| 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 TRACHEOSTOMY TUBE |
| Generic Name | TUBE TRACHEOSTOMY AND TUBE CUFF |
| Product Code | JOH |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-04 |
| Model Number | 67PFSS40 |
| Catalog Number | 67PFSS40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-27 |