MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for IMS LIDOCAINE LARYNG-O-JET KIT 6300 manufactured by Ims Amphastar.
[27693103]
Patient Sequence No: 1, Text Type: N, H10
[27693104]
Patient was in the operating room for shoulder arthroscopy procedure. Just prior to intubation, laryngeal tracheal anesthetic tube was being pulled out and the tip broke off. Tip was 1. 5 inches long. The tip ended up in the trachea and then the slipped down into the left bronchus. Immediately recognized and was retrieved with a bronchoscope and snare. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5131267 |
| MDR Report Key | 5131267 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-09-30 |
| Date of Event | 2014-09-12 |
| Report Date | 2015-09-30 |
| Date Reported to FDA | 2015-09-30 |
| Date Reported to Mfgr | 2015-09-30 |
| Date Added to Maude | 2015-10-07 |
| 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 | 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 | 3 |
| Brand Name | IMS LIDOCAINE LARYNG-O-JET KIT |
| Generic Name | APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA |
| Product Code | CCT |
| Date Received | 2015-10-07 |
| Returned To Mfg | 2014-09-26 |
| Model Number | 6300 |
| Catalog Number | 6300 |
| Lot Number | DJ015D4 |
| ID Number | STOCK #6300 |
| Device Expiration Date | 2016-03-31 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMS AMPHASTAR |
| Manufacturer Address | 1886 SANTA ANITA AVE. SOUTH ELMONTE CA 91733 US 91733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-07 |