BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 10687379 · Received October 15, 2020

    Report

    Report Number
    1213809-2020-00717
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 28, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 6 BD 1ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED DIFFICULTY CONNECTING THE SYRINGE TO THE MATING COMPONENT RESULTING IN LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309628, BATCH NO. 8241546. WE HAVE HAD A NUMBER OF PATIENT COMPLAINTS REGARDING 1ML LUER-LOK SYRINGE COMPATIBILITY WITH NEEDLES FOR OUR INJECTION KITS. WE ARE CURIOUS WHETHER THERE HAVE BEEN REPORTS OF LEAKAGE FROM SYRINGES AND/OR NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152752 BD 1ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 8241546 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other