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

Catalog Number	1140
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer complaint cannot be confirmed based only on the information provided.To perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.There is no inventory of the involved product code available at the facility and is no longer part of nuevo laredo manufactured product codes.The device history record of batch number 74l2201857 could not be conducted since the dhr is not available at nuevo laredo facility.However, according to sap system, no non conformance reports were originated for the lot in question that can be associated to the complaint reported.However, if defective sample becomes available at a later date this complaint will be updated as applicable.
Event or Problem Description
It was reported that: "bite block broke while inside the patients mouth.The tip of the bite block detached from the bite block itself- white handle and green block.The patient was intubated with a protected airway.There was no harm or consequence and the patient was reported as fine." confirmed to happen on two separate devices from the same lot: associated complaints 3004365956-2025-0002.

• 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: 22141417
• Report Number: 3004365956-2025-00027
• Device Sequence Number: 12820321
• Product Code: MNK
• UDI-Device Identifier: 14026704640352
• UDI-Public: (01)14026704640352(11)221125(17)280428(10)74L2201857(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 1140
• Device Lot Number: 74L2201857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2022
• 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
• Patient Sex: Unknown