BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS

    MDR report key: 11143711 · Received January 9, 2021

    Report

    Report Number
    8041187-2021-00012
    Event Type
    Malfunction
    Date Received
    January 9, 2021
    Date of Event
    December 3, 2020
    Report Date
    January 6, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO SAMPLES WERE RECEIVED WITH A SEALED UNIT PACKAGE FOR INVESTIGATION. FROM THE SAMPLES, THE NEEDLE WAS OBSERVED TO BE CONNECTED WITH THE SYRINGE BARREL TIP. THE SAMPLES WERE SUBJECTED TO THE NEEDLE PULL TEST AND RESULTS SHOWED THAT THE SAMPLES ARE WITHIN THE PRODUCT SPECIFICATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 15 SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS SEPARATED AT THE MATING COMPONENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ON (B)(6), 2020, THE DEPARTMENT FOUND THAT THE CONNECTION OF THE SYRINGE NEEDLE WAS LOOSE, EVEN IF THE NEEDLE IS TIGHTENED, IT IS EASY TO FALL OFF DURING THE VACCINATION. THE SAMPLE HAS BEEN SENT BACK TO THE (B)(4) QUALITY SUPERVISION DEPARTMENT, BATCH NUMBER 9123544, AND THE DEPARTMENT REQUIRES 30 1ML NEEDLES TO BE RETURNED SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40429 SYRINGE 1ML LS 25GA 5/8IN CHIN GRAPHICS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 9123544

    Patients

    Seq Age Sex Outcome Treatment
    1