BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML ALLERGY SYRINGE WITH 28 G X 1/2 IN. BD PRECISIONGLIDE¿ ATTACHED NEEDLE

    MDR report key: 6277273 · Received January 25, 2017

    Report

    Report Number
    1920898-2017-00009
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    January 3, 2017
    Report Date
    February 14, 2017
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - THE CUSTOMER RETURNED (1) LOOSE BD 1CC, 12.7MM ALLERGY SYRINGE WITHOUT ANY PACKAGING. THE SYRINGE WAS RETURNED PROPERLY CAPPED. THE SAMPLE WAS EXAMINED UNDER THE MICROSCOPE AND NO DAMAGE TO THE SHIELD WAS OBSERVED. THE SHIELD WAS REMOVED AND THE CANNULA WAS ALSO EXAMINED UNDER THE MICROSCOPE. NO DAMAGED CANNULA POINT, BLOOD, OR ANY OTHER FOREIGN MATTER WAS OBSERVED ON THE CANNULA SHAFT OR IN THE LUMEN OF THE CANNULA. NO DEFECTS WERE OBSERVED ON ANY PART OF THE RETURNED SAMPLE. SINCE THERE IS NO INDICATION THAT THE SHIELD WAS OFF IN THE BAG WITH THE CANNULA EXPOSED, THE NEEDLE STICK ISSUE ALSO CANNOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 6130958. THIS LOT WAS PACKAGED 27JUN2016. CONCLUSION - BD WAS UNABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: THIS DEVICE DOES NOT HAVE AN EXPIRATION DATE. (B)(6). DEVICE EVALUATION: IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE OF THE SUSPECT DEVICE WAS UNCAPPED AND THROUGH THE BAG. THE CUSTOMER CUT HIMSELF ON THE EXPOSED NEEDLE. HE PLACED A BAND-AID TO THE SITE BUT NO MEDICAL ATTENTION WAS SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61002 1 ML ALLERGY SYRINGE WITH 28 G X 1/2 IN. BD PRECISIONGLIDE¿ ATTACHED NEEDLE ALLERGY SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE 6130958

    Patients

    Seq Age Sex Outcome Treatment
    1 Other