MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-07-19 for LTA 360 DEGREE KIT WITH LIDOCAINE HCL TOPICAL SOLUTION, USP, 4% manufactured by Hospira, Inc..
[17141695]
During attempted intubation in the operating room, an lta 360 kit's catheter injector (lidocaine hci 4% topical solution for laryngotracheal anesthesia) broke in the trachea during administration of the local anesthesia. During direct laryngoscopy, approximately 2. 5 inches of catheter was identified in the trachea at the level of the carina. Ent was contacted emergently and a rigid direct bronchoscopy was performed to retrieve the catheter, the pt's saturation decreased briefly to the 70's during the assessment and retrieval process. The catheter injector was defective. Hospira one/ndc (b)(4), lot# 66/475-r1, exp. 1jun2010. The pt's saturation decreased briefly to the 70's during the assessment and retrieval process. The pt was intubated and surgery proceeded uneventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5016787 |
| MDR Report Key | 1766945 |
| Date Received | 2010-07-19 |
| Date Added to Maude | 2010-07-27 |
| 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 | 0 |
| Health Professional | 0 |
| 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 | LTA 360 DEGREE KIT WITH LIDOCAINE HCL TOPICAL SOLUTION, USP, 4% |
| Generic Name | NONE |
| Product Code | CCT |
| Date Received | 2010-07-19 |
| Lot Number | 66/475-R1 |
| ID Number | 00409-4698-01 |
| Device Expiration Date | 2010-06-01 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-07-19 |