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 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medwatch uf/importer report # (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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

Medwatch complaint received: "the patient was admitted with an intra-cranial bleed.He was in the neurological critical care unit (nccu) until transfer to a neuro floor approximately a month later.One week later, while being seen for a dual therapy session (pt and ot), the patient coughed forcefully and expelled a 3cm x 3cm green portion of a bite block.Note that the white portion of the bite block, which typically extends out of the mouth was no longer present.The patient reportedly did not relax his jaw during oral care and the presence of the block was unknown." additional information was received and it was reported there was no additional intervention required and no harm occurred to the patient.

• 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: victoria sandlin ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 9774726
• MDR Text Key: 191575258
• Report Number: 3004365956-2020-00069
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1