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

Model Number	IPN049847
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number of the device was not provided.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.Corrected data:.
Event or Problem Description
It was reported an "intubated patient had bite block in his mouth.Upon doing mouth care at 6 pm, the pca helping me noticed that the green part that goes between patient's teeth was in his mouth and was no longer attached to the long white part that comes out of the mouth.The white part was found in the bed by patient's neck".No patient injury or harm reported.No medical intervention reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned by the customer and sent to the manufacturing site for analysis.The manufacturing site reports: "the customer complaint is confirmed since a broke sample of product code 1140 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 issue could have been generated due to an incorrect use of the device.What the customer is reporting as "broken issue" it is actually a damaged on the device." although the complaint is confirmed, a root cause could not be established.
Event or Problem Description
It was reported an "intubated patient had bite block in his mouth.Upon doing mouth care at 6 pm, the pca helping me noticed that the green part that goes between patient's teeth was in his mouth and was no longer attached to the long white part that comes out of the mouth.The white part was found in the bed by patient's neck".No patient injury or harm reported.No medical intervention reported.Patient condition reported as "fine".

• 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
• MDR Report Key: 12951906
• Report Number: 3004365956-2021-00316
• Device Sequence Number: 4963742
• Product Code: MNK
• UDI-Device Identifier: 14026704640352
• UDI-Public: 14026704640352
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 11/18/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown