BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML S/T W/NDL 26X5/8 RB

    MDR report key: 9257111 · Received October 30, 2019

    Report

    Report Number
    1213809-2019-01083
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 11, 2019
    Report Date
    December 13, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. NO CORRECTIVE ACTIONS RECOMMENDED SINCE SAMPLES/PHOTOS WERE NOT RECEIVED TO CONFIRM THE PRODUCT DEFECT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE SYRINGE 1ML S/T W/NDL 26X5/8 RB HAS BEEN FOUND WITH THE NEEDLE BREAKING OFF DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED ONE NEEDLE BROKE AND THE PATIENT MISSED DOSE OF MEDICATION. A REPORT WAS RECEIVED 11OCT2019: ONE NEEDLE BROKE AND THEREFORE THEY WERE UNABLE TO ADMINISTER THE GATTEX DOSE THEY DREW UP AS THEY DID NOT HAVE A REPLACEMENT NEEDLE. NO ADVERSE EVENTS REPORTED FROM MISSED DOSE.

    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 1ML S/T W/NDL 26X5/8 RB HAS BEEN FOUND WITH THE NEEDLE BREAKING OFF DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED ONE NEEDLE BROKE AND THE PATIENT MISSED DOSE OF MEDICATION. PER VERBATIM: "A REPORT WAS RECEIVED (B)(6) 2019: ONE NEEDLE BROKE AND THEREFORE THEY WERE UNABLE TO ADMINISTER THE GATTEX DOSE THEY DREW UP AS THEY DID NOT HAVE A REPLACEMENT NEEDLE. NO ADVERSE EVENTS REPORTED FROM MISSED DOSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052519 SYRINGE 1ML S/T W/NDL 26X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9070752 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Other