BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8749641 · Received July 1, 2019

    Report

    Report Number
    2243072-2019-01296
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    May 26, 2019
    Report Date
    June 19, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    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

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. PMA / 510(K)#: 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 NOT 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: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN NOT 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. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN NOT BE DETERMINED AS NO SAMPLES WERE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING WITH 3 ML BD LUER-LOK¿ LUER-LOK¿ TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DEAR COMPLAINT DEPARTMENT, DESCRIPTION OF ISSUE: CUSTOMER REPORTED THAT THE SYRINGE AND NEEDLE DOESN'T SEAL PROPERLY. HE CAN INJECT INSULIN INTO HIS CARTRIDGE BUT WHEN HE TAKES OUT THE NEEDLE/SYRINGE IT DOESN'T ALLOW HIM TO REMOVE IT PROPERLY. NUMBER OF OCCURRENCES: 2".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541187 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other