BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 10933068 · Received December 2, 2020

    Report

    Report Number
    1213809-2020-00861
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 6, 2020
    Report Date
    December 29, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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 WAS REPORTED THAT THE BD 1ML SYRINGE LUER-LOK¿ TIP EXPERIENCED ISSUES WITH THE SYRINGE VOLUMETRIC ACCURACY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE MAKE STERILE PREPARATIONS AND USE THIS SYRINGE AMONG OTHER THINGS TO ADD SMALL QUANTITIES TO A SYRINGE OR IV-BAG. IN THIS CASE THE VOLUME WAS 0.25ML, BUT AFTER THE RECONCILIATION IT TURNED OUT TO BE AN AVERAGE OF 0.272ML (108.8%). MEANWHILE, ALL OTHER POSSIBLE CAUSES WERE RULED OUT AND WE SUSPECT THAT THE 1ML SYRINGE USED WAS THE CAUSE. THIS WAS ALSO CONFIRMED BY DOING SOME TESTS WITH ANOTHER SYRINGE OF THE SAME LOT (9042758) WHICH WE DO NOT HAVE.

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD 1ML SYRINGE LUER-LOK¿ TIP EXPERIENCED ISSUES WITH THE SYRINGE VOLUMETRIC ACCURACY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE MAKE STERILE PREPARATIONS AND USE THIS SYRINGE AMONG OTHER THINGS TO ADD SMALL QUANTITIES TO A SYRINGE OR IV-BAG. IN THIS CASE THE VOLUME WAS 0.25ML, BUT AFTER THE RECONCILIATION IT TURNED OUT TO BE AN AVERAGE OF 0.272ML (108.8%). MEANWHILE, ALL OTHER POSSIBLE CAUSES WERE RULED OUT AND WE SUSPECT THAT THE 1ML SYRINGE USED WAS THE CAUSE. THIS WAS ALSO CONFIRMED BY DOING SOME TESTS WITH ANOTHER SYRINGE OF THE SAME LOT (9042758) WHICH WE DO NOT HAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402251 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9042758 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1