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

Model Number IPN049847

Device Problem Material Separation (1562)

Patient Problem Laceration(s) (1946)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Qn# (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 as the lot number provided for this complaint (901549) does not correspond to the product reported by the customer; it is not a valid lot number for the manufacturing facility.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 Description

It was reported "patient has a brain injury and bites lips & mouth.Facility placed the bite guard-i confirmed that it was not secured and was in place continuously.Upon performing routine oral care, the cn found the "bite block was in the middle of his mouth not aligned with his teeth.When she moved the bite block, she saw that the green bite block piece was gone, no longer connected to the handle.The supervisor came in to assist along with rt.They got a lateral xr of the neck and could see it at the back of the throat.As they opened the patient's mouth the green piece was visualized, and they said that it was moving up and down with each breath.When they could visualize it, they were able to remove the foreign object with forceps.Patient has had some bleeding in the mouth.The patient was sent to er for evaluation of any trauma after the foreign body was removed.Bronchoscope was utilized to visualize the posterior oropharynx.The patient had a small area of erythema".

Event Description

It was reported "patient has a brain injury and bites lips & mouth.Facility placed the bite guard-i confirmed that it was not secured and was in place continuously.Upon performing routine oral care, the cn found the "bite block was in the middle of his mouth not aligned with his teeth.When she moved the bite block, she saw that the green bite block piece was gone, no longer connected to the handle.The supervisor came in to assist along with rt.They got a lateral xr of the neck and could see it at the back of the throat.As they opened the patient's mouth the green piece was visualized, and they said that it was moving up and down with each breath.When they could visualize it, they were able to remove the foreign object with forceps.Patient has had some bleeding in the mouth.The patient was sent to er for evaluation of any trauma after the foreign body was removed.Bronchoscope was utilized to visualize the posterior oropharynx.The patient had a small area of erythema".

Manufacturer Narrative

Qn#(b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports: "a visual inspection of the product involved in the complaint was performed on a sample received by the customer of product code 1140 (bite-gard molar bite block).The customer description states, "upon performing routine oral care, the cn found the "bite block was in the middle of his mouth not aligned with his teeth.When she moved the bite block, she saw that the green bite block piece was gone, no longer connected to the handle.)"; the customer complaint is confirmed since the components handle and block of the sample are separated as is describe in customer complaint description.While performing the visual inspection test on the received sample a wear on the handle was observed which is related to a correct bonding of the bite block.Based on the received sample of product 1140 (bite-gard molar bite block) provided by the customer, a disconnection between the handle and the bite block is confirmed, however based on the received sample is not possible to determine that the issue was caused by an inappropriate assembly (bonding).".

• Brand Name: HUDSON BITE-GARD MOLAR BITE BLOCK
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12287575
• MDR Text Key: 265378592
• Report Number: 3004365956-2021-00250
• Device Sequence Number: 1
• Product Code: MNK
• UDI-Device Identifier: 14026704640352
• UDI-Public: 14026704640352
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN049847
• Device Catalogue Number: 1140
• Device Lot Number: 901549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Date Manufacturer Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention