BEUDAMED
    FDA Adverse Event Injury Summary report: N

    400 DENTAL NDL 30SH

    MDR report key: 9204764 · Received October 17, 2019

    Report

    Report Number
    1017768-2019-00706
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    September 30, 2019
    Report Date
    January 7, 2020
    Manufacturer
    COVIDIEN
    Product Code
    DZM
    UDI-DI
    10884521002746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 832343 INDICATES THAT THERE WERE NOT ANY MANUFACTURING OR INSPECTION ANOMALIES RELATED TO THE CUSTOMER COMPLAINT. THERE WERE NO SAMPLES RETURNED WITH THE COMPLAINT, BUT A PHOTOGRAPH WAS SUBMITTED WITH THE COMPLAINT. THE PHOTOGRAPH WAS INSPECTED AND SHOWS AN OPEN BOX OF DENTAL NEEDLES FOR LOT 832343. ALL VISIBLE NEEDLES SEEM TO STILL BE ENCLOSED IN THEIR HARD PACK CONTAINER AND THERE IS NO INDICATION OF THE REPORTED CONDITION. PHYSICAL SAMPLES ARE REQUIRED TO DETERMINE IF THE NEEDLES ARE DETACHING FROM THE HUB OR NOT. THE REPORTED CONDITION IS NOT CONFIRMED BASED ON THE PICTURES PROVIDED IN THE COMPLAINT. THERE WERE NO MANUFACTURING ISSUES RELATED TO THE COMPLAINT ISSUED FOR THIS LOT AND A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. THE EXACT NATURE OF THE ALLEGED DEFECT COULD NOT BE DETERMINED. THE POSSIBLE ROOT CAUSES IDENTIFIED IN THIS COMPLAINT PERTAIN TO THE USER¿S APPLICATION OF THE DEVICE. IT¿S RECOMMENDED THE USER CONSULT THE INSTRUCTIONS FOR USE FOR MORE INFORMATION. SINCE THERE WERE NO FINDINGS RELATED TO THE REPORTED CONDITION, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED TO: THE CUSTOMER STATED THE NEEDLE CLEANLY DETACHED FROM THE HUB WHILE IN USE. THE DOCTOR REMOVED THE BROKEN TIP FROM THE PATIENT'S GUMS. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION OR MEDICATION REQUIRED FOR THE PATIENT. FROM: THE CUSTOMER REPORTED THAT THE NEEDLE TIP BROKE WHILE IN USE. THE DOCTOR REMOVED THE BROKEN TIP FROM THE PATIENT'S GUMS. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION OR MEDICATION REQUIRED FOR THE PATIENT.

    Description of Event or Problem · 0

    THE CUSTOMER STATED THE NEEDLE CLEANLY DETACHED FROM THE HUB WHILE IN USE. THE DOCTOR REMOVED THE BROKEN TIP FROM THE PATIENT'S GUMS. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION OR MEDICATION REQUIRED FOR THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NEEDLE TIP BROKE WHILE IN USE. THE DOCTOR REMOVED THE BROKEN TIP FROM THE PATIENT'S GUMS. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION OR MEDICATION REQUIRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996505 400 DENTAL NDL 30SH NEEDLE, DENTAL DZM COVIDIEN 8881400074 832343 10884521002746

    Patients

    Seq Age Sex Outcome Treatment
    1 Other