MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-02-01 for LTA 360 KIT * manufactured by Hospira.
[19583882]
A distal portion of the laringotracheal anesthesia (lta) injection cannula broke off and it was found in the patient's trachea. Upon retrieval it was noted the edges of the pieces were smooth - clean break.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2438494 |
| MDR Report Key | 2438494 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-02-01 |
| Date of Event | 2012-01-31 |
| Report Date | 2012-02-01 |
| Date Reported to FDA | 2012-02-01 |
| Date Added to Maude | 2012-02-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LTA 360 KIT |
| Generic Name | LTA KIT |
| Product Code | CCT |
| Date Received | 2012-02-01 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 04-320-RA |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA |
| Manufacturer Address | 275 N. FIELD DR. BLDG H2 LAKE FOREST IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-01 |