MAUDE Adverse Event Report: TELEFLEX MEDICAL BITE-GARD MOLAR BITE BLOCK; ENDOSCOPIC BITE BLOCK

Catalog Number	1140
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: 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.Additional information: there was no reported patient harm or consequence.They were discharged as per care plan.
Additional Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record of batch has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.
Event or Problem Description
It was reported that: 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.Additional information: there was no reported patient harm or consequence.They were discharged as per care plan.

• Brand Name: BITE-GARD MOLAR BITE BLOCK
• Common Device Name: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18524068
• Report Number: 3004365956-2024-00001
• Device Sequence Number: 7802060
• Product Code: MNK
• UDI-Device Identifier: 14026704640352
• UDI-Public: 14026704640352
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1140
• Device Lot Number: 74B2002409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 01/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown