BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 7298091 · Received February 26, 2018

    Report

    Report Number
    1213809-2018-00061
    Event Type
    Malfunction
    Date Received
    February 26, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 26, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTO EVALUATION: A SINGLE PHOTO OF A 3ML SYRINGE WAS RECEIVED BY BD CANAAN AND EVALUATED. THE PRODUCT WAS REPORTED TO BE FROM BATCH #7031955 (B)(4). THE SYRINGE WAS FILLED WITH APPROXIMATELY 1.6ML IF CLEAR LIQUID. THE SYRINGE HAD NO NEEDLE OR ANY OTHER DEVICE ATTACHED. SEVERAL PIECES OF UNIDENTIFIED FM COULD BE SEEN POTENTIALLY IN THE FLUID PATH INSIDE THE LIQUID. DHR REVIEW FOR BATCH 7031955 (B)(4). MANUFACTURING DATES: 02/23/2017 TO 02/24/2017. BATCH QUANTITY WAS 460,800.ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7031955 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. INVESTIGATION CONCLUSION: ROOT CAUSE UNDETERNINED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD LUER-LOK¿ SYRINGE PRIOR TO USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141759 BD LUER-LOK¿ SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7031955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other