BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB

    MDR report key: 8400137 · Received March 7, 2019

    Report

    Report Number
    1213809-2019-00307
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 13, 2019
    Report Date
    February 22, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903059240
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. PMA / 510(K)#: K980987, K951254. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURES. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A VACCINE WAS ADMINISTERED WITH A SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB LIQUID CAME SQUIRTING OUT OF THE PLUNGER SIDE. THE REPORT IS AS FOLLOWS, "VACCINE WAS DRAWN INTO THE SYRINGE FOR IMMUNIZATION AND ADMINISTRATION, CLIENT'S SKIN WAS PUNCTURED AND WHEN VACCINE WAS TO BE ADMINISTERED, LIQUID CAME SQUIRTING OUT OF THE PLUNGER SIDE. CLIENT NEEDED TO HAVE NEW VACCINE ADMINISTERED TO ALTERNATE ARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195526 SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903059240

    Patients

    Seq Age Sex Outcome Treatment
    1 Other