BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 15801641 · Received November 15, 2022

    Report

    Report Number
    1213809-2022-01003
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 24, 2022
    Report Date
    January 17, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096238
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 19-DEC-2022. H6: INVESTIGATION SUMMARY: TWELVE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. NONE OF THE SAMPLES SHOWED ANY SIGNS OF THE REPORTED DEFECT. SINCE THE REPORTED DEFECT WAS NOT CONFIRMED A MANUFACTURING ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1113470. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, THE NEEDLE IS ATTACHED TO A "CLEAR OR WHITE" PIECE AND BOTH NEEDLE AND "CLEAR OR WHITE PIECE" IS INSIDE THE NEEDLE SHIELD. THE "CLEAR OR WHITE PIECE" SITS THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, THE NEEDLE IS ATTACHED TO A "CLEAR OR WHITE" PIECE AND BOTH NEEDLE AND "CLEAR OR WHITE PIECE" IS INSIDE THE NEEDLE SHIELD. THE "CLEAR OR WHITE PIECE" SITS THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171750 BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309623 1113470 30382903096238

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown