BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 9260800 · Received October 31, 2019

    Report

    Report Number
    3002682307-2019-00582
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    July 24, 2019
    Report Date
    November 27, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 300800 LOT 180724 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. DHR SHOW NO ABNORMALITIES DURING NEEDLES MANUFACTURING. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICROLANCE¿ 3 NEEDLE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE ATTACHMENT POINT BETWEEN THE BLUE PLASTIC AND THE STEEL CANNULA, VACCINE HAS LEAKED DURING SLOW, PROPER INJECTION. DUE TO EARLY DETECTION, WE ASSUME THAT AN ADEQUATE AMOUNT OF VACCINE HAS ARRIVED IN THE MUSCLE. HOWEVER, IT WAS NOT POSSIBLE TO VACCINATE THE ENTIRE DOSE, AS APPROXIMATELY 5% OF THE INJECTION WAS LOST. UNCOMPLICATED APPLICATION POSSIBLE AFTER CHANGING THE CANNULA.

    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¿ 3 NEEDLE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE ATTACHMENT POINT BETWEEN THE BLUE PLASTIC AND THE STEEL CANNULA, VACCINE HAS LEAKED DURING SLOW, PROPER INJECTION. DUE TO EARLY DETECTION, WE ASSUME THAT AN ADEQUATE AMOUNT OF VACCINE HAS ARRIVED IN THE MUSCLE. HOWEVER, IT WAS NOT POSSIBLE TO VACCINATE THE ENTIRE DOSE, AS APPROXIMATELY 5% OF THE INJECTION WAS LOST. UNCOMPLICATED APPLICATION POSSIBLE AFTER CHANGING THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053454 BD MICROLANCE¿ 3 NEEDLE NEEDLE FMI BECTON DICKINSON, S.A. 180724

    Patients

    Seq Age Sex Outcome Treatment
    1 Other