BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN MULTI-USE DISPENSER

    MDR report key: 6395382 · Received March 10, 2017

    Report

    Report Number
    0001721729-2017-00002
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    November 18, 2016
    Report Date
    March 10, 2017
    Manufacturer
    SEPTODONT INC.
    Product Code
    EIY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION ONGOING.

    Description of Event or Problem · 1

    SPONTANEOUS REPORT. (B)(4). INITIAL INFORMATION RECEIVED BY DEALER ON 19-DEC-2016 AND ADDITIONAL INFORMATION WAS RECEIVED BY DEALER ON 28-DEC-2016. BOTH INITIAL AND ADDITIONAL INFORMATION WERE SENT TO SEPTODONT ON 28-DEC-2016. CASE 2 OF 2. LINKED WITH LOCAL REFERENCE # (B)(4) (SAME REPORTING DENTAL CLINIC, SAME DEVICE, SAME REPORTED CONCERN). THE 2 CASES CONCERN 2 DIFFERENT IDENTIFIED PATIENTS: A (B)(6) FEMALE PATIENT AND A (B)(6) MALE PATIENT. HOWEVER, IT COULD NOT BE DETERMINED WHICH OF THESE TWO PATIENTS WAS CONCERNED BY THE FOLLOWING REPORTED INFORMATION. ON (B)(6) 2016, WHILE DENTAL CLINIC STAFF (B)(6) [NAME REACTED FOR PRIVACY] WAS PLACING THE RESIN ON THE BACK TOOTH, THE SUSPECT DISPENSER HENRY SCHEIN MULTI-USE DISPENSER (LOT # NOT AVAILABLE) SNAPED AND MAKED A VERY LOUD NOISE. NOBODY WAS HURT OR INJURED BUT THE POTENTIAL FOR THE CAR PULE TO BE SWALLOWED WAS VERY HIGH. NO LOT # AVAILABLE. ADDITIONAL NARRATIVE RECEIVED ON 06-FEB-2017: A UNIDOSE RESIN CAPSULE WAS PLACED IN THE SUSPECT MULTIUSE DISPENSER AND THE DENTIST WAS SQUEEZING THE RESIN INTO THE MOUTH AS USUAL. THE SUSPECT DEVICE "POPPED" THE VERY MOMENT THE DEVICE HANDLE WAS SQUEEZED. WHEN ASKED WHICH PART OF THE SUSPECT MULTIUSE DISPENSER WAS BROKEN, IT IS INDICATED BY THE COMPLAINANT IT WAS AT "THE SILVER THING AT THE TIP OF THE GUN [SUSPECT MULTIUSE DISPENSER] WHEN YOU PUT THE UNIDOSE RESIN", "THE HARD OUTER SHELL BROKE" AND IT MADE SUCH A LOUD NOISE IT SEEMED LIKE AN ACTUAL GUN WAS FIRED. ACCORDING TO THE COMPLAINANT, THE REPORTED BREAKAGE HAD ALREADY HAPPENED TO 3 DIFFERENT MULTIUSE DISPENSERS. ADDITIONAL INFORMATION RECEIVED ON 07-FEB-2017: IT WAS CONFIRMED BY THE COMPLAINANT THAT THE PREVIOUS TWO MULTIUSE DISPENSERS "BROKE IN THE EXACT SAME WAY.. WHILE DISPERSING THE RESIN CAPSULE IN THE MOUTH.. WE ARE VERY LUCKY NONE OF THE PIECES WENT DOWN THE PATIENT'S MOUTH." ON 08-FEB-2017, IT WAS DETERMINED BY SEPTODONT THAT THE REPORTED MALFUNCTION FAILED TO PERFORM AS INTENDED AND THAT THE SUSPECT DEVICE IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. ON 21-FEB-2017, SEPTODONT CONTACTED SUPPLIER OF THE A "OTHER NUMBER" ON THE RETURNED DEVICE SAMPLE WAS IDENTIFIED AS "I6802", WHICH PERMIT SEPTODONT TO DETERMINE DEVICE MANUFACTURING DATE AS 09-JUL-2014. CALL LOG WAS RECEIVED FROM QA ON CURRENT INVESTIGATION STATUS. CAUSALITY ASSESSMENT ON 10-MAR-2017 BY (B)(4) ON INITIAL INFORMATION RECEIVED ON 02-FEB-2017, AND ADDITIONAL INFORMATION RECEIVED ON 06-FEB-2017, 07-FEB-2017, 08-FEB-2017 AND 21-FEB-2017: SERIOUSNESS: SERIOUS (DETERMINED BY SEPTODONT THAT THE REPORTED MALFUNCTION FAILED TO PERFORM AS INTENDED AND THAT THE SUSPECT DEVICE IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR). LISTEDNESS/EXPECTEDNESS: DEVICE BREAKAGE: UNLISTED EU; UNEXPECTED US/(B)(4). NO ADVERSE EVENT: LISTED EU; EXPECTED US/(B)(4). CAUSALITY: LATENCY - UNKNOWN. RECOGNIZED ASSOCIATION - NO. ANALYSIS - THE REPORTER HAD 2 SIMILAR EVENTS OF DEVICE BREAKAGE IN 2 IDENTIFIED PATIENTS. THE DEVICE WAS RETURNED TO QUALITY DEPARTMENT ONLY FOR ONE OF THEM. BREAKAGE OF THE DEVICE COULD BE DUE TO ANOMALY OF THE MATERIAL, HOWEVER CALL LOG RECEIVED FROM QA ON CURRENT INVESTIGATION STATUS STATED THAT THE RETURNED DISPENSER APPEARED TO BE DROPPED, AND THAT IT WAS HEAVILY USED DUE TO BUILDUP ON THE PIN. THEREFORE, WITHOUT OTHER INFORMATION, SINCE NO ADVERSE EVENT WAS REPORTED AND CONSIDERING STATE OF USE OF THE DEVICE, THE CAUSALITY BETWEEN THE DISPENSER AND DEVICE BREAKAGE WAS ASSESSED AS UNLIKELY. THE EVENT NO ADVERSE EVENT WAS NOT ASSESSABLE. DECHALLENGE - NA. RECHALLENGE - NA. CONCLUDED CAUSALITY WHO: UNLIKELY FOR DEVICE BREAKAGE, NOT ASSESSABLE FOR NO ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179128 HENRY SCHEIN MULTI-USE DISPENSER MULTI-USE DISPENSER EIY SEPTODONT INC. I6802

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention