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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL BITE-GARD MOLAR BITE BLOCK; ENDOSCOPIC BITE BLOCK
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TELEFLEX MEDICAL BITE-GARD MOLAR BITE BLOCK; ENDOSCOPIC BITE BLOCK Back to Search Results
Catalog Number 1140
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2024
Event Type  malfunction  
Event Description
It was reported that: "after extubation the bedside nurse found the green part of the device in the patient's mouth and the white part in the bed." there was no patient injury and no medical intervention required.
 
Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record has been reviewed and no issues or discrepancies were found which could potentially relate to this complai nt.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.No corrections can be established at this moment since the product sample is not available for evaluation.Product sample is necessary to perform a proper investigation to determinate the cause and the corresponding corrections.
 
Manufacturer Narrative
(b)(4).The reported complaint of "detached - bite block" was confirmed based upon the sample received.The customer returned one unit of 1140 bite-gard molar bite block for investigation.Visual examination of the returned sample revealed that the white handle was broken.The observed damage is indicative of breaking during use.The returned sample appeared used as there was biological material present on the device.A device history record review was performed with no evidence of a manufacturing related cause.Teleflex will continue to monitor and trend on this issue.
 
Event Description
It was reported that: "after extubation the bedside nurse found the green part of the device in the patient's mouth and the white part in the bed." there was no patient injury and no medical intervention required.
 
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Brand Name
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
kevin don bosco
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18765788
MDR Text Key336085735
Report Number3004365956-2024-00011
Device Sequence Number1
Product Code MNK
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number1140
Device Lot Number74F2301523
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
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