MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for LARYNGOTRACHEAL ANESTHESIA DEVICE manufactured by Unk.
[93221649]
Tee procedure complicated by device malfunction involving a laryngotracheal aerosolization device. The product was removed from packaging with no apparent defect and inserted into the patient's airway via a glidescope. The physician involved in this care reports that the cannula was never bent during this process, and there were no abnormalities of the patient's airway. Upon attempted removal of the device, the tip of the cannula broke and was lodged in the patient's vocal cords. The patient needed to be intubated and pulmonology was called for bronchoscopy to remove the piece. The patient was then transferred to the icu and had no further complications related to the device malfunction. International medication systems, (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073576 |
| MDR Report Key | 7063334 |
| Date Received | 2017-11-28 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-11-16 |
| Date Added to Maude | 2017-11-28 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | LARYNGOTRACHEAL ANESTHESIA DEVICE |
| Generic Name | LARYNGOTRACHEAL ANESTHESIA DEVICE |
| Product Code | CCT |
| Date Received | 2017-11-28 |
| Lot Number | DL067G7 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-28 |