BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T W/NDL 25X5/8 RB

    MDR report key: 18253697 · Received December 3, 2023

    Report

    Report Number
    1213809-2023-01381
    Event Type
    Malfunction
    Date Received
    December 3, 2023
    Date of Event
    November 8, 2023
    Report Date
    January 25, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    PR 9230808- FOLLOW UP MDR FOR DEVICE EVALUATION. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, 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. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL 25X5/8 RB HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UNIT OF MEASURE PRINTED DOWN SYRINGE ISN'T STRAIGHT AND DOESN'T MATCH UP TO DRAW UP CORRECT DOSE - MOST OF THESE HAVE BEEN TOSSED." FURTHER INFORMATION RECEIVED ON 11/19/2023: IF YOU ARE UNABLE TO SEND A SAMPLE, COULD YOU PROVIDE ANY PHOTO/VIDEO OF THE REPORTED ISSUE? NO. I REPORTED IT TO THE VENDOR (COVETRUS) AND DISPOSED OF THE TUB. WHAT IS THE OUTCOME? ARE THERE ANY ADVERSE EVENTS/SERIOUS INJURIES? NO. WHEN THE DEFECT WAS NOTICED IT WAS BROUGHT TO MY ATTENTION. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? YES. HAD TO PULL A NEW NEEDLE. WHAT TYPE OF PROCEDURE IS BEING PERFORMED? BLOOD DRAW, AND SEDATIVE INJECTION. WHAT WAS THE MEDICATION/FLUID IN USE AT THE TIME OF THE EVENT? UNKNOWN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694546 BD SYRINGE 1ML S/T W/NDL 25X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3102086 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown