MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-25 for LIDOCAINE TOPICAL SOLUTION 4% WITH LARYNGOTRACHEAL CANNULA 6300 manufactured by Ims Amphastar.
[4920920]
Anesthesiologist noticed that tip of plastic cannula of an lta kit broke off and went into patient's trachea. While trying to dislodge it, the tip slipped down into the bronchus. An ent physician was called and removed the piece from the bronchus. There was no apparent harm to patient, surgery proceeded and patient was discharged later in the day. Dose or amount: 4 ml, frequency: one time, route: intra-tracheal. Diagnosis or reason for use: intubation aid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038377 |
| MDR Report Key | 4128650 |
| Date Received | 2014-09-25 |
| Date of Report | 2014-09-19 |
| Date of Event | 2014-09-12 |
| Date Added to Maude | 2014-10-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIDOCAINE TOPICAL SOLUTION 4% WITH LARYNGOTRACHEAL CANNULA |
| Generic Name | LTA KIT |
| Product Code | CCT |
| Date Received | 2014-09-25 |
| Model Number | 6300 |
| Catalog Number | 6300 |
| Lot Number | DJ015D4 |
| ID Number | 7632963005 |
| Device Expiration Date | 2016-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMS AMPHASTAR |
| Manufacturer Address | SOUTH EL MONTE CA 91733 US 91733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-09-25 |