MAUDE Adverse Event Report: INTERNATIONAL MEDICATION SYSTEM LARYNG-O-JET KIT

Model Number STOCK #6300

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2015

Event Type  Other  

Event Description

Lta dispensing unit broke while being deployed inside pt's airway.The broken piece was retained in pt's bronchial stem.Emergency bronchoscopy and removal of foreign body from pt's bronchial stem was performed.Pt was reintubated and the scheduled procedure acdf c 5-6 and c 6-7 was performed.

• Brand Name: LARYNG-O-JET KIT
• Manufacturer (Section D): INTERNATIONAL MEDICATION SYSTEM; 1886 santa anita ave.; south el monte CA 91733
• MDR Report Key: 5353145
• MDR Text Key: 35619695
• Report Number: 5353145
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: STOCK #6300
• Device Catalogue Number: NDC 76329-6300-5
• Device Lot Number: DJ024AS
• Other Device ID Number: 12/31/2016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2015
• Distributor Facility Aware Date: 12/12/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 107