BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNIVERSAL BITE BLOCK - ADULT

    MDR report key: 19411061 · Received May 28, 2024

    Report

    Report Number
    2938401-2024-00002
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    April 8, 2024
    Report Date
    June 6, 2024
    Manufacturer
    B&B MEDICAL TECHNOLOGIES
    Product Code
    JAY
    UDI-DI
    00850008733086
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE USER FACILITY ON 05/31/24.THE PATIENT WAS A 64 YEAR OLD FEMALE WHOSE DENTAL STRUCTURES APPEARED TO BE OK AT THE TIME. THE BITE BLOCK WAS IN USE FOR LESS THAN OR EQUAL TO 1 HOUR DURING A PROCEDURE WHICH UTILIZED THE ENSOETM DEVICE, P/N: ECD02-A - LOT# 199131423. WHEN THE PATIENT WAS MOVED INTO RECOVERY IT WAS DISCOVERED THAT THE CROWN FROM THEIR UPPER LEFT INCISOR HAD FALLEN OUT. NO MEDICAL INTERVENTION WAS REQUIRED. THE AGE OF THE DENTAL CROWN WAS NOT AVAILABLE. THE LOT NUMBER FOR DEVICE IN USE WAS LOT # N3A2304. THE DEVICE HISTORY RECORD FOR THIS BATCH WAS PREVIOUSLY REVIEW PRIOR TO THE INITIAL REPORT. THERE WERE NO NON-CONFORMING MATERIAL REPORTS OR DEVIATIONS FOUND BEFORE, DURING OR AFTER PRODUCTION. REJECTION RATES DURING IN PROCESS INSPECTIONS WERE AT ACCEPTABLE LEVELS AND THE DEVICES WERE MANUFACTURED TO THEIR SPECIFICATIONS WITH THE APPROPRIATE REVISION OF THE INSTRUCTIONS FOR USE. THE EVENT IS STILL CONSIDERED TO BE AN ISOLATED INCIDENT. NO FURTHER ACTION IS REQUIRED. THE RESULTS OF THIS INVESTIGATION WILL REMAIN FILED WITHIN THE COMPANY INTERNAL COMPLAINT FILES FOR STATISTICAL USE.

    Additional Manufacturer Narrative · 0

    B&B MEDICAL TECHNOLOGIES WAS ABLE TO GET IN CONTACT WITH CUSTOMER AT (B)(6) HOSPITAL IN (B)(6) CA ON (B)(6) 2024. THE PATIENTS' TOOTH WAS NOT CHIPPED AS ORIGINALLY REPORTED, BUT IT WAS ONE OF THE PATIENTS DENTAL CROWNS THAT HAD FALLEN OUT. THE CUSTOMER ALSO SUGGESTED THAT THE PATIENT MAY HAVE HAD PRE-EXISTING DENTAL ISSUES PRIOR TO THE INCIDENT INVOLVING THE UNIVERSAL BITE BLOCK. A FOLLOW UP EMAIL CONTAINING INVESTIGATIONAL QUESTIONS WAS ALSO SENT TO THE CUSTOMER THAT DAY. THE CUSTOMER WAS CONTACTED AGAIN ON (B)(6) 2024 TO CHECK THE STATUS OF THE INVESTIGATIONAL QUESTIONS AND THE COMPANY WAS INFORMED THAT THE HOSPITAL SAFETY COMMITTEE WOULD BE PROVIDING A RESPONSE. THE COMPANY IS STILL ATTEMPTING TO CONTACT THE HOSPITAL AS OF (B)(6) 2024. THE LOT NUMBER FOR THE BITE BLOCK INVOLVED WAS NOT AVAILABLE. OVER THE LAST 6 MONTHS THE CUSTOMER HAS BEEN SHIPPED PRODUCT FROM LOT NUMBERS N3A2304, N2I0102, N2H2603, AND N2C2201. THE DEVICE HISTORY FILES FOR THESE FOUR LOTS WERE REVIEWED AND THERE WERE NO DEVIATIONS FOUND DURING THEIR PRODUCTION. REJECTION RATES DURING IN PROCESS INSPECTIONS WERE AT ACCEPTABLE LEVELS AND THE DEVICES WERE ALL MANUFACTURED TO THEIR SPECIFICATIONS WITH THE APPROPRIATE REVISION OF THE INSTRUCTIONS FOR USE. BY DESIGN, THE UNIVERSAL BITE BLOCKS ARE CONSTRUCTED OF A SOFT, NON-BRITTLE POLYPROPYLENE INTENDED TO CRUSH OR COLLAPSE RATHER THAN CRACK OR BREAK APART. THERE WAS NO EVIDENCE FOUND WITHIN THE COMPANY COMPLAINT FILES OF ANY PAST DENTAL ISSUES CAUSED BY THE ADULT UNIVERSAL BITE BLOCK. WITHIN THE LAST 10 YEARS THE PRODUCT HAS RECEIVED A < 0.00014% COMPLAINT RATE, DEEMING THE PRODUCTS TO BE STATISTICALLY SAFE AND LOW RISK. A REVIEW OF THE PRODUCT RISK MANAGEMENT ACTIVITIES CONCLUDED THAT THE BENEFIT OF PROTECTING AIRWAY INTEGRITY IN INTUBATED PATIENTS OUTWEIGH THE LOW-PROBABILITY RISK OF DAMAGING ARTIFICIAL OR NATURAL DENTAL STRUCTURES. NO CORRECTIVE OR PREVENTIVE ACTIONS REQUIRED. THE RESULTS OF THIS INVESTIGATION WILL BE FILED WITHIN THE B&B MEDICAL TECHNOLOGIES INTERNAL COMPLAINT FILES FOR STATISTICAL USE. THIS COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT AND THE FILE WILL BE CLOSED. A FOLLOW UP REPORT MAY BE GENERATED IF NEW INFORMATION IS RECEIVED FROM THE CUSTOMER.

    Description of Event or Problem · 0

    CHIEF ANESTHESIOLOGIST WITH EL CAMINO MOUNTAIN VIEW HOSPITAL REPORTED THAT A PATIENT HAD BITTEN DOWN ON THE BITE BLOCK AND CHIPPED HIS TOOTH.

    Description of Event or Problem · 0

    CHIEF ANESTHESIOLOGIST WITH (B)(6) HOSPITAL REPORTED THAT A PATIENT HAD BITTEN DOWN ON THE BITE BLOCK AND CHIPPED HIS TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836935 UNIVERSAL BITE BLOCK - ADULT ENDOTRACHEAL TUBE BITE BLOCK JAY B&B MEDICAL TECHNOLOGIES 11160 N3A2304 00850008733086

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Other ENSOETM| ENSOETM DEVICE