BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCUJECT DENTAL NEEDLE 30 GAUGE

    MDR report key: 260475 · Received January 20, 2000

    Report

    Report Number
    1220331-2000-00001
    Event Type
    Other
    Date Received
    January 20, 2000
    Date of Event
    December 30, 1999
    Report Date
    January 14, 2000
    Manufacturer
    NISSHO CORP. MEDICAL DIV.
    Product Code
    DZM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MT, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM A DENTIST OF AN ADVERSE EVENT THAT OCCURRED ASSOCIATED WITH ACCUJECT DENTAL NEEDLE 30 GAUGE SHORT. PT WAS SEEN IN DENTAL OFFICE FOR THE EXTRACTION OF A PRIMARY TOOTH "T" (SECONDARY PRIMARY MOLAR). THE DENTIST PERFORMED A LOWER RIGHT MANDIBULAR BLOCK. XYLOCAINE 2% 1:100,000 WAS INJECTED WITH AN ACCUJECT DENTAL NEEDLE 30 GAUGE SHORT (LOT # 980601 OR 970927). ON INJECTION, THE NEEDLE BROKE OFF AT THE HUB, IMBEDDING IN THE TISSUE. THE BROKEN NEEDLE THEN PUSHED INTO THE MUSCLE WHERE IT DISAPPEARED. THE TOOTH EXTRACTION CONTINUED SUCCESSFULLY. THE PT WAS SEEN BY TWO ORAL SURGEONS ON CONSULT. THE ORAL SURGEONS BOTH RECOMMENDED THAT THE NEEDLE BE LEFT IN PLACE AS IT WAS DOING NO HARM. IT WAS ALSO RECOMMENDED TO CONTINUE TO MONITOR THE SITUATION, AND IF THE NEEDLE BEGINS TO CAUSE A PROBLEM, IT WILL NEED TO BE REMOVED. ADD'L INFO REQUESTED.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION RECEIVED ON 1/14/2000 CLARIFIED THE LOT # OF THE ACCUJECT NEEDLE WAS 98F01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUJECT DENTAL NEEDLE 30 GAUGE DISPOSABLE DENTAL NEEDLE DZM NISSHO CORP. MEDICAL DIV. NDC # 0186-9009-05 98F01

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other XYLOCAINE 2% 1:100,000 12/30/99.