MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-01 for LARYNG-O JET KIT STERILE PAK manufactured by Hospira.
[74446134]
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, approx 2. 5 inches of catheter was identified in the trachea. Ent was contacted emergently and a rigid direct bronchoscopy was performed to retrieve the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069523 |
| MDR Report Key | 6541055 |
| Date Received | 2017-05-01 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-03-14 |
| Date Added to Maude | 2017-05-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LARYNG-O JET KIT STERILE PAK |
| Generic Name | LARYNG-O JET KIT STERILE PAK |
| Product Code | CCT |
| Date Received | 2017-05-01 |
| Lot Number | DJ05216 |
| Device Expiration Date | 2018-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA |
| Manufacturer Address | ST. LOUIS MO 63141 US 63141 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-05-01 |