BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 8805472 · Received July 18, 2019

    Report

    Report Number
    1213809-2019-00762
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    July 1, 2019
    Report Date
    August 21, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO AND ONE EMPTY TRAY WITHOUT TOP WEB WITH A LOOSE 10ML SYRINGE INSIDE WERE RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS OBSERVED TO HAVE A MOLDING FLASH ON THE PLUNGER ROD¿S THUMB REST. THE FLASH EXTENDED ACROSS THE THUMB REST AND CONTINUED ON TWO OF THE OPPOSING RIBS. THE FLASH OBSERVED WAS OUTSIDE OF THE ALLOWED SPECIFICATION AND IS REJECTABLE. POTENTIAL ROOT CAUSE FOR THE FLASH DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. 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 · 0

    IT HAS BEEN REPORTED THAT ONE SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAS BEEN FOUND WITH A MOLDING DEFECT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS PARTICULATE FOUND ON THE SYRINGE. PER EMAIL: THERE IS PARTICULATE ON THE TOP OF THE SYRINGE FROM LOT 9002961.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAS BEEN FOUND WITH A MOLDING DEFECT BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS PARTICULATE FOUND ON THE SYRINGE. PER EMAIL: THERE IS PARTICULATE ON THE TOP OF THE SYRINGE FROM LOT 9002961.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594935 SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9002961 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other