BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE PRECISIONGLIDE 30X1/2IN

    MDR report key: 9219808 · Received October 22, 2019

    Report

    Report Number
    3003916417-2019-00531
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 24, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE PRECISIONGLIDE 30X1/2IN EXPERIENCED A CLOGGED/BLOCKED NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE BOUGHT A 0.30 X 13 MM NEEDLE BOX FROM LOT 9112781 WITH MANUFACTURING AND WHEN USING IT WE REALIZED THAT THERE WAS NO LIGHT, NEEDLE WAS CLOGGED, WE ARE ALSO HAVING A HARD TIME INJECTING THE LIQUID WE HAVE TO MAKE A STRONG PRESSURE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE PRECISIONGLIDE 30X1/2IN EXPERIENCED A CLOGGED/BLOCKED NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE BOUGHT A 0.30 X 13 MM NEEDLE BOX FROM LOT 9112781 WITH MANUFACTURING AND WHEN USING IT WE REALIZED THAT THERE WAS NO LIGHT, NEEDLE WAS CLOGGED, WE ARE ALSO HAVING A HARD TIME INJECTING THE LIQUID WE HAVE TO MAKE A STRONG PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015799 NEEDLE PRECISIONGLIDE 30X1/2IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 9112781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other