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 Consequences Or Impact To Patient (2199)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Medwatch complaint received: "the biteguard was placed in the correct position once lma was secured at beginning of case.Upon emergence, the pt was awakened and the lma removed with no complications.The pt had the biteguard in his mouth, but was not forcibility biting down.I attempted to remove the biteguard with minimal pressure and the white handle separated from the green bite piece.Thankfully, i was able to grab the green piece with my hand and, luckily, the pt did not bite my finger in the process." additional information received from customer reports there was no injury to the patient.The provider was able to remove the piece of the bitegard from the patient's mouth without any further issues.

Manufacturer Narrative

(b)(4).Medwatch # mw5092334.The sample was not returned; however, the customer provided two photos for evaluation.During the visual inspection of the photos it was observed that the bite block was broken as described in the customer complaint.No other issues were found.The customer complaint was confirmed based on the visual inspection of the received photos.Although the complaint is confirmed, there is not sufficient evidence to assure this issue was originated during the manufacturing process.The root cause for the condition reported could not be identified.To perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Medwatch complaint received: "the biteguard was placed in the correct position once lma was secured at beginning of case.Upon emergence, the pt was awakened and the lma removed with no complications.The pt had the biteguard in his mouth, but was not forcibily biting down.I attempted to remove the biteguard with minimal pressure and the white handle separated from the green bite piece.Thankfully, i was able to grab the green piece with my hand and, luckily, the pt did not bite my finger in the process." additional information received from customer reports there was no injury to the patient.The provider was able to remove the piece of the bitegard from the patient's mouth without any further issues.

• Brand Name: HUDSON BITE-GARD MOLAR BITE BLOCK
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9751564
• MDR Text Key: 191573543
• Report Number: 3004365956-2020-00052
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LARYNGEAL MASK (LMA); LARYNGEAL MASK (LMA)