BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ HYPODERMIC NEEDLE

    MDR report key: 9274067 · Received November 4, 2019

    Report

    Report Number
    3002682307-2019-00587
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 18, 2019
    Report Date
    November 20, 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
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLE FOR 300600 LOT 190114 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 DURING USE OF THE BD MICROLANCE¿ HYPODERMIC NEEDLE THERE IS AN ISSUE WITH LEAKAGE FROM THE SIDES OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: IS THERE A PROBLEM WITH NEEDLES 300600 WITH LOT 190114? SEVERAL COMPLAINTS COME IN, I WILL ASK FOR DETAILS. WHEN INJECTING THE PRODUCT EMPTY, THE PRODUCT LEAVES THE SIDES OF THE NEEDLE AND NOT THROUGH THE BEVEL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 DURING USE OF THE BD MICROLANCE¿ HYPODERMIC NEEDLE THERE IS AN ISSUE WITH LEAKAGE FROM THE SIDES OF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IS THERE A PROBLEM WITH NEEDLES 300600 WITH LOT 190114? SEVERAL COMPLAINTS COME IN, I WILL ASK FOR DETAILS. WHEN INJECTING THE PRODUCT EMPTY, THE PRODUCT LEAVES THE SIDES OF THE NEEDLE AND NOT THROUGH THE BEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065188 BD MICROLANCE¿ HYPODERMIC NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 190114

    Patients

    Seq Age Sex Outcome Treatment
    1 Other