MAUDE Adverse Event Report: UNIVERSAL BITE BLOCK; ENDOSCOPIC BITE BLOCK

Lot Number N9E2702

Device Problems Difficult to Remove (1528); Device Fell (4014)

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

Event Date 09/21/2019

Event Type  malfunction  

Event Description

While securing the bite block around the pt's et tube, the plastic blue cap fell off of the cable tie and landed in pt's mouth.It was very difficult to remove the blue cap from the pt's mouth.

• Brand Name: UNIVERSAL BITE BLOCK
• Type of Device: ENDOSCOPIC BITE BLOCK
• MDR Report Key: 9295677
• MDR Text Key: 166194637
• Report Number: MW5090983
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: N9E2702
• 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): Other
• Patient Age: 77 YR