BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 9334743 · Received November 18, 2019

    Report

    Report Number
    3002682307-2019-00612
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 28, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH PHOTOS FOR CATALOG 300400 LOT 171109 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO SHOW A CANNULA BROKEN AT THE LEVEL OF THE HUB. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD COULD NOT RELATED THE REPORTED ISSUE WITH OUR MANUFACTURING PROCESS. ANY BREAKAGE ISSUE IS RARE UNLESS THERE WAS SOME INAPPROPRIATE USE OF THE PRODUCT, FOR EXAMPLE, BECAUSE OF SOME BENDING OF THE NEEDLE WHILE INJECTING. IN ADDITION, THE CANNULA PULLOUT TEST IS ALSO EVALUATED FOR COMPLIANCE. A DEFINITE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. THE DEFECT COULD BE RELATED WITH AN INCORRECT HANDLING OF THE PRODUCT. AS THIS IS THE FIRST TIME THIS LOT WAS REPORTED FOR THIS DEFECT, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. CONCLUSION(S): BASED ON ABOVE RESULTS, BD CONFIRMS THE INDICATED FAILURE MODE. HOWEVER, SINCE REVIEW OF DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, REFERENCE SAMPLE RESULTS WERE WITHIN SPECIFICATIONS AND AFTER EXAMINATION OF AFFECTED SAMPLE PICTURE, BD COULD NOT RELATE THE REPORTED ISSUE WITH OUR MANUFACTURING PROCESS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE¿ HYPODERMIC NEEDLE BROKE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF ASPIRATION OF THE VACCINE, A NEEDLE BROKE AT THE BASE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD MICROLANCE¿ HYPODERMIC NEEDLE BROKE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF ASPIRATION OF THE VACCINE, A NEEDLE BROKE AT THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131071 BD MICROLANCE¿ HYPODERMIC NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 171109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other