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

Model Number	IPN049847
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "we have recently had issues with the bitegard oral bite blocks breaking in patients mouths when they are difficult to remove." there was no report of patient injury.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that: "we have recently had issues with the bitegard oral bite blocks breaking in patients mouths when they are difficult to remove." there was no report of patient injury.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4) the sample was received for analysis.While performing the visual inspection to received sample, part of the handle was observed on the bite block which indicates that the damage issue could be generated due to an incorrect use of the device.What the customer is reporting as "broken issue" it is actually a damage on the device.No other issues were found.The customer complaint is confirmed since a broke sample of product code (b)(4)was received for evaluation.While performing the visual inspection to received sample, part of the handle was observed on the bite block which indicates that the damage could have been generated due to an incorrect use of the device.What the customer is reporting as "broken issue" it is actually a damage on the device.Although the complaint is confirmed based on the sample provided, the customer complaint cannot be confirmed as manufacturing issue.Based on previous statements it is not possible to establish corrective actions.

• Brand Name: HUDSON 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 ; 9193614124
• MDR Report Key: 15068866
• Report Number: 3004365956-2022-00044
• Device Sequence Number: 5504298
• Product Code: MNK
• UDI-Device Identifier: 14026704640352
• UDI-Public: 14026704640352
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2022

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
• Device Model Number: IPN049847
• Device Catalogue Number: 1140
• Device Lot Number: 74J2001806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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: N/A.; N/A.
• Patient Sex: Unknown