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).
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 3004365956-2025-00027.
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 3004365956-2025-00028 and 3004365956-2025-00027.
Additional Manufacturer Narrative
Qn #: (b)(4).The reported complaint of "detached - bite block" was confirmed based upon the sample received.The customer returned one unit of 1140 bite-gard molar bite block for investigation.Visual examination of the returned sample revealed that the white handle was broken.The observed damage is indicative of breaking during use, but the exact root cause could not be determined.A review of records in our system did not identify any deviations or findings with the reported lot number.Based on the investigation of the returned sample, the root cause of this reported issue could not be determined.Teleflex will continue to monitor and trend on this issue.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22141632
• Report Number: 3004365956-2025-00028
• Device Sequence Number: 7276441
• 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,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; NOT REPORTED
• Patient Sex: Unknown