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

Catalog Number 1140

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

Event Description

It was reported "patient was orally intubated and actively biting the block.Two hours later, the patient had chewed on it and separated the green guard from the white handle.The nurse found the white handle in the patient's bed, and the green part ended up in the back of the patient's throat.The nurse had to use kelly clamps to get it out".No patient injury or desaturation reported.Patient condition reported as "fine".

• Brand Name: HUDSON BITE-GARD MOLAR BITE BLOCK
• Type of Device: 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: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 11201440
• MDR Text Key: 227812899
• Report Number: 3004365956-2021-00010
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1140
• Device Lot Number: 74G2001835
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2020
• 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
• Treatment: LARYNGEAL MASK (LMA)