MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-02-23 for BIVONA MICROLARYNGEAL WIRE TUBE 65W050 manufactured by Smiths Medical Asd, Inc..
[1424398]
According to reporter, they were unable to ventilate post intubation. They visualized the interior of the microlaryngeal tube with bronchoscope. Tube was occluded against the anterior wall of trachea. Tube removed, patient recovered after tube removed.
Patient Sequence No: 1, Text Type: D, B5
[8441946]
Device evaluation: the device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2010-00032 |
| MDR Report Key | 1623193 |
| Report Source | 01,05,06 |
| Date Received | 2010-02-23 |
| Date of Report | 2010-02-16 |
| Date of Event | 2010-01-14 |
| Date Facility Aware | 2010-01-14 |
| Report Date | 2010-02-16 |
| Date Reported to FDA | 2010-02-16 |
| Date Mfgr Received | 2010-01-14 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2010-05-13 |
| 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 | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 5700 WEST 23RD AVE. |
| Manufacturer City | GARY IN 46406 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46406 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIVONA MICROLARYNGEAL WIRE TUBE |
| Generic Name | KAC-TUBE LARYNGECTOMY |
| Product Code | KAC |
| Date Received | 2010-02-23 |
| Returned To Mfg | 2010-02-01 |
| Model Number | NA |
| Catalog Number | 65W050 |
| Lot Number | 1623622 |
| ID Number | NA |
| Device Expiration Date | 2014-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | GARY IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-23 |