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 |