MAUDE Adverse Event Report: HUDSON RCI / TELEFLEX MEDICAL BITEGARD; ENDOSCOPIC BITE BLOCK

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2020

Event Type  Injury  

Event Description

The bitegard was placed in the correct position once lma was secured at beginning of case.Upon emergence, the pt was awakened and the lma removed with no complications.The pt had the bitegard in his mouth but was not forcibly biting down.I attempted to remove the bitegard with minimal pressure and the white handle separated from the green bite piece.Thankfully i was able to grab the green piece with my hand and luckily the pt did not bite my finger in the process.Fda safety report id# (b)(4).

• Brand Name: BITEGARD
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): HUDSON RCI / TELEFLEX MEDICAL ; MD
• MDR Report Key: 9601527
• MDR Text Key: 175915268
• Report Number: MW5092334
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention