MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-03-17 for BIVONA? ADULT TTS? TRACHEOSTOMY TUBE CUSTOM 3.5 TTS FLEXTEND + 1/EA FT19FN35NGE076S manufactured by Smiths Medical Asd,inc..
[183874021]
Investigation results completed on a smiths medical slicone-bivona tube. The device was visually inspected and revealed the teflon tubing used to bridge the airway line to the lumen in the shaft had worked its way inside the pilot balloon. Device was able to inflate and deflate. The complaint was validated and root cause unknown as no lot number was revealed. Teflon tubing was in the correct location when the device was assembled; otherwise, the opening that joins the external airway line to the internal lumen would have been blocked by adhesive. The investigation could not determine a definitive root cause for the migration of the teflon tubing into the pilot balloon. Since no adverse trends have been identified related to this issue, no corrective actions are planned at this time.
Patient Sequence No: 1, Text Type: N, H10
[183874022]
Information was received that smiths bivona? Adult tts? Tracheostomy tube reported during cleaning, a small piece of plastic was noticed coming out of the pilot line. The user was concerned over foreign body being ingested into the stoma. No patient adverse events reported and a new trach change took place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01986 |
| MDR Report Key | 9845167 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 5700 WEST 23RD AVENUE, |
| Manufacturer City | GARY,, IN |
| 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 | 2020-03-17 |
| Returned To Mfg | 2020-02-18 |
| Model Number | CUSTOM 3.5 TTS FLEXTEND + 1/EA |
| Catalog Number | FT19FN35NGE076S |
| Lot Number | 3782497 |
| Operator | LAY USER/PATIENT |
| 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 NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Congenital Not Applicablenomaly; 2. Other; 3. Required No Informationntervention | 2020-03-17 |