BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD NEEDLE

    MDR report key: 11506988 · Received March 17, 2021

    Report

    Report Number
    2243072-2021-00812
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 11, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION AS NO SAMPLE, LOT, OR BATCH NUMBER WERE PROVIDED."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD NEEDLE CONTRIBUTED TO A DIRTY NEEDLE STICK DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED NEEDLE STICK. VERBATIM: PER CUSTOMER'S RESPONSE ON (B)(6) 2021. DO YOU HAPPEN TO HAVE THE DATE OF EVENT?(B)(6) 2021. WHAT IS THE LOT# AND MATERIAL # FOR THE NEEDLE? THE PACKAGING WAS NOT SAVED SO CAN¿T VERIFY WHAT LOT NUMBER WAS USED. DID THE NURSE SEEK MEDICAL ATTENTION FOLLOWING NEEDLE STICK? EMPLOYEE SENT FOR LAB TESTING TO RULE OUT HIV/HEP B EXPOSURE FROM THE NEEDLE POKE. DO YOU HAVE THE NEEDLE AVAILABLE? NO. DO YOU HAVE PHYSICAL SAMPLES TO RETURN, IF SO, PLEASE LET US KNOW AND WE WILL SEND YOU A RETURN LABEL? NO. THE ATTACHED IMAGE IS A PLUNGER FROM ITEM #741113 (3CC SYRINGE). WHEN IT WAS BEING USED, THE PLUNGER BENT LIKE THIS AND THE NURSE¿S OTHER HAND WAS STUCK WITH THE NEEDLE. NO NEED TO REPLACE THE ONE SYRINGE, BUT WANTED TO PASS IT ALONG IN CASE THIS IS A MANUFACTURER DEFECT THAT NEEDS ATTENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407057 UNSPECIFIED BD NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention