MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BITE-GARD ORAL BITE BLOCK,INTL; ENDOSCOPIC BITE BLOCK

Catalog Number 41140

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided at the time of this report.Trend analysis for this device and device family, for the period (b)(6) 2017 to (b)(6) 2018, found four complaints were received for the same issue.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed based only on the information provided.To perform a proper and thorough investigation, it is necessary to evaluate the sample involved in this complaint.If the device sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "after a few hours of use, the patient bit hard which resulted in the white handle becoming separated from the green molar guard." patient condition reported as "fine".

• Brand Name: HUDSON BITE-GARD ORAL BITE BLOCK,INTL
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7690227
• MDR Text Key: 114051590
• Report Number: 3004365956-2018-00219
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 41140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1