BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 8946386 · Received August 29, 2019

    Report

    Report Number
    1911916-2019-00888
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE CONSIDER THIS MDR AS CANCELED AS THE INFORMATION WAS REVALUATED AND DOES NOT MEET OUR REPORTING CRITERIA. H3 OTHER TEXT : SEE. H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MIXED PRODUCT WAS FOUND BEFORE USE WITH A BD¿ BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PLEASE SEE THE BELOW CONCERN FROM THE EMS STONEGATE, CALGARY ZONE, REGARDING A BLUNT FILLED NEEDLE 18G X 1.5¿, (MF#305180), (LOT# ALL). THE CONCERN: THE NON-FILTERED BLUNT FILL NEEDLES REQUIRED FOR THE POINT OF CARE TESTING DEVICES ARE IN A LOOKALIKE PACKAGING WITH THE FILTERED BLUNT FILL NEEDLES. LABELING IS IDENTICAL EXCEPT FOR SLIGHTLY DIFFERENT COLORS AND VERY SMALL TEXT THAT INDICATES IF IT IS FILTERED NEEDLE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 MIXED PRODUCT WAS FOUND BEFORE USE WITH A BD¿ BLUNT FILL NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PLEASE SEE THE BELOW CONCERN FROM THE EMS STONEGATE, CALGARY ZONE, REGARDING A BLUNT FILLED NEEDLE 18G X 1.5¿, (MF# (B)(4)), (LOT# ALL). THE CONCERN: THE NON-FILTERED BLUNT FILL NEEDLES REQUIRED FOR THE POINT OF CARE TESTING DEVICES ARE IN A LOOKALIKE PACKAGING WITH THE FILTERED BLUNT FILL NEEDLES. LABELING IS IDENTICAL EXCEPT FOR SLIGHTLY DIFFERENT COLORS AND VERY SMALL TEXT THAT INDICATES IF IT IS FILTERED NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741949 BD¿ BLUNT FILL NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BECTON DICKINSON AND COMPANY UNKNOWN 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other