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

Catalog Number	1140
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the green part of the bite-gard block snapped off in the patient's mouth when trying to remove it for pac.The white part also separated, and the green portion became stuck in the patient's mouth.Sedation and the use of inotropes was required to remove the block with forceps.Additional information indicated that the bite block was in place as the patient was biting down, so sedation was necessary to relax the patient's mouth and retrieve the block.A propofol bolus was administered for sedation, and noradrenaline was started to offset the hypotensive effects of propofol, which was discontinued once the effects wore off.There was no injury to the patient, and the patient's outcome was unaffected by this event.
Additional Manufacturer Narrative
Qn#(b)(4).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.The returned sample appeared used as there was biological material present on the device.A device history record review was performed and no relevant findings were identified.The reported complaint was confirmed based upon the sample received.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 device history record review was performed with no evidence of a manufacturing related cause.Teleflex will continue to monitor and trend on this issue.
Event or Problem Description
It was reported that the green part of the bite-gard block snapped off in the patient's mouth when trying to remove it for pac.The white part also separated, and the green portion became stuck in the patient's mouth.Sedation and the use of inotropes was required to remove the block with forceps.Additional information indicated that the bite block was in place as the patient was biting down, so sedation was necessary to relax the patient's mouth and retrieve the block.A propofol bolus was administered for sedation, and noradrenaline was started to offset the hypotensive effects of propofol, which was discontinued once the effects wore off.There was no injury to the patient, and the patient's outcome was unaffected by this event.

• Brand Name: HUDSON RCI 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21196539
• Report Number: 3004365956-2025-00004
• Device Sequence Number: 12835340
• Product Code: MNK
• UDI-Device Identifier: 14026704640352
• UDI-Public: (01)14026704640352(11)240613(17)350108(10)73F2400470(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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 73F2400470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2024
• 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