BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON BITE-GARD ORAL BITE BLOCK,INTL

    MDR report key: 5065036 · Received September 9, 2015

    Report

    Report Number
    3004365956-2015-00277
    Event Type
    Malfunction
    Date Received
    September 9, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 19, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    JXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT. TWO PICTURES OF CATALOG NUMBER 41140 (BITE-GARD ORAL BITE BLOCK, INTL) WERE RECEIVED FOR ANALYSIS. DURING THE VISUAL INSPECTION IT CAN BE OBSERVED THE COMPONENT PART NUMBER 10752 HANDLE, ORAL BITE BLOCK IS DETACHED FROM COMPONENT PART NUMBER 10707 BITE BLOCK, LARGE. NO OTHER ISSUES WERE FOUND. THE DEVICE HISTORY RECORD REVIEW SHOWED THAT THERE WERE NO ISSUES RELATED TO THIS COMPLAINT NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THE MATERIAL. DURING THE VISUAL INSPECTION ON THE RECEIVED PICTURES IT WAS OBSERVED THAT THE HANDLE WAS DETACHED OUT FROM THE BITE BLOCK. ALSO, IT WAS OBSERVED RESIDUES OF THE BITE BLOCK ON THE HANDLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THE BITE BLOCK WAS DAMAGED. BASED ON THE VISUAL EXAM, THE REPORTED COMPLAINT IS CONFIRMED. THE DEVICE HISTORY RECORD OF BATCH NUMBER 74E1400379 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD BE POTENTIALLY RELATED TO THE COMPLAINT. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECIFICATIONS. THE LAST DHR OF COMPONENT (B)(4) WAS REVIEWED TO VERIFY THE PROCESS PARAMETERS AND USED MATERIAL AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS ISSUE. NO CORRECTIVE ACTION CAN BE IMPLEMENTED SINCE THE FAILURE MODE IS NOT RELATED TO THE MANUFACTURING PROCESS OF THE PRODUCT. A CONCLUSION CODE COULD NOT BE FOUND AS THE COMPLAINT WAS CONFIRMED; HOWEVER, A ROOT CAUSE WAS NOT ESTABLISHED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE BITE BLOCK WAS PLACED IN THE PATIENT'S MOUTH DUE TO THE PATIENT BITING THE ENDOTRACHEAL TUBE. SOON AFTER PLACEMENT, THE BITE BLOCK COMPLETELY FELL APART AND THE PATIENT HAD BITTEN THROUGH THE MAIN BODY OF THE BITE BLOCK. ALL PARTS WERE REMOVED FROM THE PATIENT'S MOUTH. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE BITE BLOCK WAS PLACED IN THE PATIENT'S MOUTH DUE TO THE PATIENT BITING THE ENDOTRACHEAL TUBE. SOON AFTER PLACEMENT, THE BITE BLOCK COMPLETELY FELL APART AND THE PATIENT HAD BITTEN THROUGH THE MAIN BODY OF THE BITE BLOCK. ALL PARTS WERE REMOVED FROM THE PATIENT'S MOUTH. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596630 HUDSON BITE-GARD ORAL BITE BLOCK,INTL BITE BLOCK JXL TELEFLEX MEDICAL 74E1400379

    Patients

    Seq Age Sex Outcome Treatment
    1