BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SHARPS CONTAINER 0.45

    MDR report key: 7505038 · Received May 10, 2018

    Report

    Report Number
    2243072-2018-00233
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    April 15, 2018
    Report Date
    August 7, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTAINER WAS MANUFACTURED IN WEEK 09 OF 2011. (7 YEARS OLD). QUALITY AND PRODUCTION RECORDS FOR THIS PERIOD WERE EXAMINED AND NO ERRORS IN MANUFACTURE OR PERFORMANCE WERE FOUND. THE WALL THICKNESS OF THE PENETRATION SITE WAS MEASURED AND FOUND TO BE 1.74 MM. THIS EXCEEDS THE MINIMUM FRONTIER INTERNAL THICKNESS REQUIREMENTS BY 0.17MM. THE THICKNESS OF 1.74 MM (ADJACENT TO THE PENETRATION SITE) PROVIDED A PENETRATION RESISTANCE FORCE OF 18.1 N, EXCEEDING THE REQUIREMENT OF BOTH BS EN ISO 23907:2012 & NF X 30-511 WHICH STATES THAT THE FORCE MUST BE 15 N OR ABOVE. THE CONTAINER CONTENTS JUST EXCEED THE FILL LINE; NO DEFECTS WERE FOUND WITH THE UNIT AND IT MET ALL THE REQUIREMENTS OF THE INTERNATIONAL STANDARDS. IT IS DIFFICULT TO COMMENT ON WHY THE NEEDLE PENETRATED THE SIDE WALL, HOWEVER, THE MOST LIKELY CAUSE IS THAT THE USER FORCED ONE OF THE THREE ¿INFLUVAC¿ VACCINE SYRINGES INTO THE CONTAINER. AS IT WAS BEING PUSHED INTO THE SHARPSAFE IT CAME INTO CONTACT WITH THE NEEDLE AND THE NEEDLE WAS THEN FORCED THROUGH THE SIDE, PENETRATING IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INSULIN NEEDLE CAME THRU A BD¿ SHARPS CONTAINER 0.45 AND RESULTED IN A CONTAMINATED NEEDLE STICK TO A NURSE. THE NURSE HAD BLOOD BORNE PATHOGEN TESTING. THERE WAS NO ADDITIONAL INFORMATION REGARDING TREATMENT OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 INSULIN NEEDLE CAME THRU A BD¿ SHARPS CONTAINER 0.45 AND RESULTED IN A CONTAMINATED NEEDLE STICK TO A NURSE. THE NURSE HAD BLOOD BORNE PATHOGEN TESTING. THERE WAS NO ADDITIONAL INFORMATION REGARDING TREATMENT OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348109 BD¿ SHARPS CONTAINER 0.45 SHARPS COLLECTOR MMK BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention