BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB

    MDR report key: 8453791 · Received March 26, 2019

    Report

    Report Number
    8041187-2019-00252
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057888
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PMA / 510(K)#: K980987; K161170. INVESTIGATION SUMMARY: REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED AS PER SPECIFICATION IN ACCORDING WITH THE IN-PROCESS SAMPLING PLANS AND OUT - GOING SAMPLING PLANS. THE RETURNED PHOTO WAS OBSERVED TO HAVE MISSING SCALE ON THE SYRINGE. MISSING SCALE COULD HAVE PROBABLY CAUSED BY EJECT GATE AT THE APEX MACHINE. THE MANUFACTURING PROCESS WAS REVIEWED. IT WAS SUSPECTED THAT THE EJECT GATE AT APEX MACHINE WAS NOT FULLY CLOSED AFTER PT CLEAR MACHINE ERROR. THIS MAY CAUSE THE REJECT PARTS TO PASS THROUGH WHEN THEY START RUNNING THE MACHINE. INVESTIGATION CONCLUSION: THE RETURNED PHOTO WAS OBSERVED TO HAVE MISSING SCALE ON THE SYRINGE. ROOT CAUSE DESCRIPTION: MISSING SCALE COULD HAVE PROBABLY CAUSED BY EJECT GATE AT THE APEX MACHINE. THE MANUFACTURING PROCESS WAS REVIEWED. IT WAS SUSPECTED THAT THE EJECT GATE AT APEX MACHINE WAS NOT FULLY CLOSED AFTER PT CLEAR MACHINE ERROR. THIS MAY CAUSE THE REJECT PARTS TO PASS THROUGH WHEN THEY START RUNNING THE MACHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB HAD SCALE MARKING ERROR. THE FOLLOWING WAS REPORTED, "SCALE MISSING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247418 SYRINGE 3ML LL W/NDL ECLIPSE 22X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7114289 30382903057888

    Patients

    Seq Age Sex Outcome Treatment
    1 Other