BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8426233 · Received March 15, 2019

    Report

    Report Number
    2243072-2019-00493
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    February 24, 2019
    Report Date
    March 15, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A 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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. PMA / 510(K)#: K980987 OR K151766. 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 A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP HAD SYRINGE ISSUE DURING USE. THE FOLLOWING WAS REPORTED, "MATERIAL NO.: 309657. BATCH/LOT: M118997. IT WAS REPORTED THAT THERE WAS A "SYRINGE ISSUE WHEN CUSTOMER ATTEMPTED TO FILL INSULIN FROM VILE. CUSTOMER TEXT: CUSTOMER REPORTED SYRINGE ISSUE WHEN CUSTOMER ATTEMPTED TO FILL INSULIN FROM VILE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218868 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other