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 Consequences Or Impact To Patient (2199)

Event Date 04/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the defect was not provided at the time of this report.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.A root cause is unknown.To perform a proper and thorough investigation to confirm the alleged defect, determine a root cause and establish any corresponding corrective actions, it is necessary to evaluate the sample involved in this complaint.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "on this occasion the nurse was cleaning the patient's teeth, brushing around the block and holding the bite block handle when it the handle snapped off from the body of the block." medical intervention reported was retrieval of bite block with forceps.There was no injury or complication reported related to the alleged device event.

Manufacturer Narrative

(b)(4).The sample was received for evaluation.While performing the visual inspection test on the received sample , part of the handle was observed on the bite block which indicates that the damage issue was generated due to an incorrect use of the device.What the customer is reporting as handle snapped off issue is actually damage on the device.A device history record (dhr) review was performed on the potential lot numbers reported (74e1701003, 74b1701004, 74f1701954) and there were no issues found that could relate to the reported complaint.

Event Description

Customer complaint alleges "on this occasion the nurse was cleaning the patient's teeth, brushing around the block and holding the bite block handle when it the handle snapped off from the body of the block." medical intervention reported was retrieval of bite block with forceps.There was no injury or complication reported related to the alleged device event.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7462446
• MDR Text Key: 106704350
• Report Number: 3004365956-2018-00144
• Device Sequence Number: 1
• Product Code: MNK
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 41140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR