MAUDE Adverse Event Report: TELEFLEX MEDICAL RCI BITE GUARD; ENDOSCOPIC BITE BLOCK

Catalog Number 1140

Patient Problem Foreign Body In Patient (2687)

Event Date 11/08/2023

Event Type  Injury  

Event Description

Anesthesiologist used an oral bite guard for patient to protect airway.After the procedure was complete and the patient was waking up the patient bit down on the mouth guard and it snapped apart into two pieces.The device broke (handle separated from the bite guard that was positioned between the pts molars) patient was placed at risk of aspiration and/or possibility of swallowing the part that was still retained in the mouth.Due to patient still being sedated and uncooperative it took 5 minutes to retrieve the broken piece from the patients mouth.Has manufacture date with no expiration date.Manufactured date 02/27/2020.

• Brand Name: RCI BITE GUARD
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 18266947
• MDR Text Key: 329896396
• Report Number: MW5148761
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1140
• Device Lot Number: 74B2002409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White