BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7914144 · Received September 27, 2018

    Report

    Report Number
    1213809-2018-00631
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    July 31, 2018
    Report Date
    September 24, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PHOTO AND ONE LOOSE 10ML ASSEMBLED SYRINGE WAS RECEIVED AND REPORTED TO BE FROM BATCH #8002709 (P/N 301029). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE WHITE LINT LIKE FOREIGN MATTER LOOSE ON THE SURFACE OF THE STOPPER. THE FOREIGN MATTER IS GREATER THAN LEVEL 3 IN SIZE WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. IN ADDITION TO THE FOREIGN MATTER FOUND INSIDE THE SYRINGE, THERE ARE SMALL DARK PARTICULATES OF SOLID FOREIGN MATTER IN THE NONFLUID PATH OF THE SYRINGE, THE PRINTED SCALE OF THE SYRINGE LOOKS FADED FROM THE 3ML LINE TO THE 10ML LINE. ALL THOSE OBSERVATIONS ARE INDICATIONS THAT THE PRODUCT HAS BEEN MANIPULATED. THE POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER FOUND IS UNDETERMINED SINCE THE PRODUCT APPEARS TO BE MANIPULATED. THERE IS NOT ENOUGH EVIDENCE TO CONFIRM THAT THE CONTAMINATION FOUND IN THE 10ML SYRINGE IS ASSOCIATED WITH THE SYRINGE MANUFACTURING PROCESS. AT THIS POINT, IT IS NOT CLEAR HOW AND WHERE THE PRODUCT WAS CONTAMINATED. FURTHERMORE, THE MATERIALS USED FOR MACHINE CLEANING ARE NOT SIMILAR TO THE WHITE FOREIGN MATTER FOUND INSIDE THE SYRINGE. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LINT IN THE BD SYRINGE LUER-LOK¿ TIP. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755585 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8002709

    Patients

    Seq Age Sex Outcome Treatment
    1 Other