BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL NEEDLE

    MDR report key: 6721488 · Received July 18, 2017

    Report

    Report Number
    9681835-2017-00023
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 12, 2017
    Report Date
    July 18, 2017
    Manufacturer
    TERUMO CORPORATION - KOFU
    Product Code
    DZM
    PMA / PMN Number
    K864970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UDI NUMBER IS NOT REQUIRED FOR THE REPORTED DEVICE. (B)(4). THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE NEEDLE TUBE WAS DAMAGED AND DETACHED FROM ITS BASE. A CLOSER VERIFICATION IN DETAIL OF THE CROSS SECTIONAL VIEW OF THE SNAPPED NEEDLE FOUND IT WAS ELLIPTICALLY DEFORMED AND THE TUBE APPEARED TO BE STRETCHED AND WAS EVENTUALLY DETACHED FROM THE BASE. TWO (2) RETENTION SAMPLES WERE EVALUATED FOR ELASTICITY OF FLEXURAL STRENGTH. EVERY CRITERION WAS CHECKED THROUGH METHODS REGULATED BY JIS STANDARDS (JIS T 6130: STERILE DENTAL INJECTION NEEDLES FOR SINGLE USE), AND EVERY CATEGORY FULFILLED THE REQUIREMENT. A REVIEW OF THE MANUFACTURER INSPECTION RECORD OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. NO IRREGULAR FINDINGS WERE OBSERVED IN TERMS OF O.D. AND WALL THICKNESS OF THE NEEDLE. BOTH CRITERIONS WERE CONFIRMED TO BE WITH STANDARD SPECIFICATION. A SEARCH OF THE COMPLAINT FILE FOUND NO OTHER REPORT WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE INSTRUCTIONS-FOR-USE (IFU) WITH STATEMENTS AS THE FOLLOWING: "IF THE SAFETY MECHANISM FAILS TO ACTIVATE, CAREFULLY DISPOSE THE PRODUCT APPROPRIATELY." DO NOT BEND THE NEEDLE PRIOR TO USE, AS BREAKAGE AND POSSIBLE PATIENT INJURY MAY RESULT." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF KOFU FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681835. EXEMPTION NUMBER E2015026.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED NEEDLE BREAKAGE WITH THE INVOLVED DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: (1) THE PATIENT WAS GIVEN ANESTHESIA WITH A DENTAL NEEDLE; (2) WHEN AN ADDITIONAL SHOT WAS INJECTED, THE DOCTOR DID NOT FEEL ANY PENETRATION RESISTANCE AS IT WAS BEING PENETRATED IN THE PATIENT; (3) SHORTLY AFTER THE NEEDLE WAS THOROUGHLY CHECKED, IT WAS FOUND COMPLETELY SEPARATED FROM THE HUB; (4) THE DOCTOR ASKED IF THE PATIENT HAD SWALLOWED THE FRAGMENT BY ACCIDENT; (5) THE PATIENT HAD LATER CLAIMED SENSE OF DISCOMFORT AT THE THROAT; (6) A PANORAMIC X-RAY WAS TAKEN WITH NO PHYSICAL IMAGE OF THE NEEDLE FRAGMENT; (7) FOR EXTRA PRECAUTION, THE DOCTOR OBTAINED THE PATIENT'S AGREEMENT TO ACCOMPANY THE PATIENT TO SAPPORO HIGASHI TOKUSHUKAI HOSPITAL FOR ANOTHER X-RAY EXAMINATION; (8) VISUAL IMAGE OF THE NEEDLE FRAGMENT HOWEVER, WAS NOT SEEN DURING THE IN-DEPTH MEDICAL CHECKUP; (9) AT THE CLINIC, THE DAMAGED FRAGMENT WAS BEING SEARCHED FOR AND EVENTUALLY DISCOVERED AS BEING TRAPPED IN A FILTER UNDERNEATH THE SPIT BOWL; AND (10) THE PATIENT WAS REPORTED TO BE IN THE 30 AGE RANGE, AN EXACT AGE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503369 DENTAL NEEDLE DENTAL NEEDLE DZM TERUMO CORPORATION - KOFU NA 160523

    Patients

    Seq Age Sex Outcome Treatment
    1