BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ MINI PEN NEEDLE

    MDR report key: 8304921 · Received February 5, 2019

    Report

    Report Number
    2243072-2019-00161
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 17, 2019
    Report Date
    February 19, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLE LEAKED DURING THE INJECTION AND THE CONSUMER HAD "HIGHER NUMBERS" FOR THE GLUCOSE LEVELS. IT WAS ALSO REPORTED THAT THE INSULIN FLOW "STOPPED BEFORE COMPLETE DOSAGE", CAUSING THE CONSUMER TO PRESS HARDER ON THE BUTTON TO "COMPLETE DOSAGE". BRAND NAME: BD ULTRA-FINE¿ MINI PEN NEEDLE. MEDICAL DEVICE CATALOG #:320119. UNIQUE IDENTIFIER (UDI) #: (B)(4). PMA / 510(K)#: K162516.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. A ROOT CAUSE COULD ALSO NOT BE DETERMINED BECAUSE OF THIS. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK DUE TO UNKNOWN LOT NUMBER FOR LEAKAGE, GLUCOSE LEVEL & DIFFICULT/UNABLE TO OPERATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLE LEAKED DURING THE INJECTION AND THE CONSUMER HAD "HIGHER NUMBERS" FOR THE GLUCOSE LEVELS. IT WAS ALSO REPORTED THAT THE INSULIN FLOW "STOPPED BEFORE COMPLETE DOSAGE", CAUSING THE CONSUMER TO PRESS HARDER ON THE BUTTON TO "COMPLETE DOSAGE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD ULTRA-FINE¿ MINI PEN NEEDLE LEAKED DURING THE INJECTION AND THE CONSUMER HAD "HIGHER NUMBERS" FOR THE GLUCOSE LEVELS. IT WAS ALSO REPORTED THAT THE INSULIN FLOW "STOPPED BEFORE COMPLETE DOSAGE", CAUSING THE CONSUMER TO PRESS HARDER ON THE BUTTON TO "COMPLETE DOSAGE".

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: 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. DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD ULTRA-FINE¿ MINI PEN NEEDLE LEAKED DURING THE INJECTION AND THE CONSUMER HAD "HIGHER NUMBERS" FOR THE GLUCOSE LEVELS. IT WAS ALSO REPORTED THAT THE INSULIN FLOW "STOPPED BEFORE COMPLETE DOSAGE", CAUSING THE CONSUMER TO PRESS HARDER ON THE BUTTON TO "COMPLETE DOSAGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101738 BD ULTRA-FINE¿ MINI PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other